Generator, Oxygen, Portable

FDA product code CAW · 282 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5440
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-05 – 2026-09-23

CAW 2026-09-23

Portable Oxygen Concentrator (OX-1A-E, OX-1B)

Applicant Oxytek Medical Technology Co., Ltd.

K number K254289

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CAW 2026-08-14

Portable Oxygen Concentrator (PO1 5B, PO1 6B)

Applicant BMC Medical Co., Ltd.

K number K260171

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CAW 2026-06-17

Portable Oxygen Concentrator

Applicant Honsun (Nantong) Co., Ltd.

K number K252399

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CAW 2026-05-29

Oxygen Concentrator (OX-5A, OX-5C)

Applicant Oxytek Medical Technology Co., Ltd.

K number K252965

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CAW 2026-04-23

OxyGo Portable Oxygen Concentrator (1400-7000)

Applicant Mv Life, LLC

K number K252407

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CAW 2026-03-26

DeVilbiss 5 Liter Oxygen Concentrator (555)

Applicant Devilbiss Healthcare, LLC

K number K253549

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CAW 2025-12-29

Oxygen Concentrator (J10A)

Applicant Foshan Kycare Medical Equipment Co., Ltd.

K number K251534

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CAW 2025-12-22

Portable oxygen concentrator (JLO-190P)

Applicant Shenzhen Homed Medical Device Co., Ltd.

K number K252616

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CAW 2025-12-22

Oxygen Concentrator-P2-O5E

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K number K251764

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CAW 2025-12-16

V series portable oxygen concentrator (V5, V5C, V6, V6C)

Applicant Shenzhen Harveymed Technology Co., Ltd.

K number K252268

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CAW 2025-12-09

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Applicant Devilbiss Healthcare, LLC

K number K250805

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CAW 2025-11-21

Oxygen Concentrator (J5A)

Applicant Foshan Kycare Medical Equipment Co., Ltd.

K number K251607

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CAW 2025-09-29

Portable oxygen concentrator (JAY-1000P)

Applicant Longfian Scitech Co., Ltd.

K number K243833

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CAW 2025-08-27

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

Applicant Nanjing Yinuoji Medical Technology Co., Ltd.

K number K250625

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CAW 2025-08-21

Portable Oxygen Concentrator (JM-P50A)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

K number K251130

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CAW 2025-07-11

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Applicant Caire, Inc.

K number K250671

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CAW 2025-06-05

Portable Oxygen Concentrator (Spirit-3)

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K number K242736

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CAW 2025-02-28

Portable Oxygen Concentrator (P2-TOC)

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K number K242718

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CAW 2024-12-06

Oxygen Concentrator (ZY-10AB/115)

Applicant Foshan Care Medical Technology Co., Ltd.

K number K240840

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CAW 2024-12-06

Rugged Oxygen Generator (ROG) (RO01-00001)

Applicant Molecular Products , Ltd.

K number K240561

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CAW 2023-11-09

Oxygen Concentrator

Applicant Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

K number K230969

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CAW 2023-10-18

Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K number K230702

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CAW 2023-10-05

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)

Applicant Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.

K number K223740

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CAW 2023-07-20

Oxygen concentrator

Applicant Zhengzhou Olive Electronic Technology Co., Ltd.

K number K222920

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CAW 2023-06-30

Inogen Rove 6

Applicant Inogen, Inc.

K number K230052

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CAW 2023-06-22

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K number K223379

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CAW 2023-05-31

Oxus Sieve Beds

Applicant Oxus, Inc.

K number K211056

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CAW 2023-04-28

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K number K213825

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CAW 2022-12-09

Inogen Rove 4 Portable Oxygen Concentrator

Applicant Inogen

K number K222086

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CAW 2022-12-08

Oxygen Concentrator, Model JAY-5AW

Applicant Longfian Scitech Co., Ltd.

K number K213210

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CAW 2022-06-03

Portable Oxygen Concentrator, model: P2-E6

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K number K210371

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CAW 2022-04-08

Oxygen Concentrator

Applicant Foshan Mic Medical Technology Co., Ltd.

K number K202389

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CAW 2021-04-12

Invacare Platinum 5NXG Oxygen Concentrator

Applicant Invacare Corporation

K number K203210

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CAW 2021-03-02

X-PLO2R

Applicant Belluscura, LLC

K number K203086

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CAW 2020-08-06

Invacare Perfecto2V Oxygen Concentrator

Applicant Invacare Corporation

K number K200890

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CAW 2020-07-24

Aer X

Applicant 3B Medical, Inc.

K number K200496

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CAW 2020-07-20

Owgels Oxygen Concentrator

Applicant Guangzhou Life Light Electronic Technology Co., Ltd.

K number K191875

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CAW 2020-05-07

Nuvo Nano Portable Oxygen Concentrator

Applicant Nidek Medical Products, Inc.

K number K192693

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CAW 2020-02-29

Kingon P2 Oxygen Concentrator

Applicant Qingdao Kingon Medical Science and Technology Co.

K number K190304

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CAW 2019-08-29

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity

Applicant Invacare Corporation

K number K191159

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CAW 2019-01-10

CONTEC Oxygen Concentrator

Applicant Contec Medical System Co., Ltd.

K number K180837

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CAW 2018-12-20

O2 Concepts Oxlife Independence Model 301-0001

Applicant O2 Concepts, LLC

K number K182454

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CAW 2018-06-01

Oxygen Concentrator

Applicant Sysmed (China) Co., Ltd.

K number K172234

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CAW 2018-03-23

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

Applicant Devilbiss Healthcare, LLC

K number K172648

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CAW 2017-05-24

GCE Zen-O Portable Oxygen Concentrator

Applicant Oxus, Inc.

K number K162433

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CAW 2016-09-27

Invacare Platinum Mobile Oxygen Concentrator

Applicant Invacare Corporation

K number K160630

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CAW 2013-11-27

ROGS

Applicant Molecular Products , Ltd.

K number K131016

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CAW 2013-02-28

MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD

Applicant Nidek Medical Products, Inc.

K number K123738

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CAW 2012-10-25

OMNI 3 OXYGEN SYSTEM

Applicant Caire, Inc.

K number K120785

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CAW 2012-09-21

TROOPER OXYGEN CONCENTRATOR

Applicant Vbox, Inc.

K number K121260

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CAW 2012-07-24

O2PAK OXYGEN GENERATOR

Applicant Pacific Precision Products

K number K120566

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CAW 2012-07-17

A&J 5L POCA SERIES OXYGEN CONCENTRATOR

Applicant Zhongshan A&J Medical Equipment Co., Ltd.

K number K121531

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CAW 2012-05-02

CAIRE COMPANION 5 OXYGEN CONCENTRATOR

Applicant Caire, Inc.

K number K121167

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CAW 2011-12-28

LIFECHOICE OXYGEN CONCENTRATOR

Applicant Inova Labs, Inc.

K number K113317

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CAW 2011-11-04

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR

Applicant Respironics, Inc.

K number K111885

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CAW 2011-07-01

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

Applicant Precision Medical, Inc.

K number K103563

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CAW 2011-03-28

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

Applicant Airsep Corp.

K number K101154

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CAW 2011-02-11

O2-IN-A-BOX, O2-IN-A-BOX

Applicant Geto2, Inc.

K number K102750

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CAW 2011-01-21

DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION

Applicant Pacific Consolidated Industries, LLC

K number K100957

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CAW 2010-11-29

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES

Applicant Sequal Technologies Co., Ltd.

K number K100920

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CAW 2010-11-09

CARE ZY5BA OXYGEN CONCENTRATOR

Applicant Foshan Care Medical Technology Co., Ltd.

K number K102245

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CAW 2010-04-02

MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY

Applicant Merits Health Products Co., Ltd.

K number K091716

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CAW 2010-01-14

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

Applicant Nidek Medical Products, Inc.

K number K093308

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CAW 2010-01-07

POGS, MODEL 65/130

Applicant On Site Gas Systems, Inc.

K number K092636

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CAW 2009-12-31

MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES

Applicant Sequal Technologies Co., Ltd.

K number K091541

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CAW 2009-11-24

AXS-590 SERIES

Applicant Swr International, Ltd.

K number K091650

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CAW 2009-10-23

GAS TRANSFILL

Applicant Respironics Inc., Sleep & Home Respiratory Group

K number K091191

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CAW 2009-10-20

OMNI 2 OXYGEN SYSTEM

Applicant Sequal Technologies, Inc.

K number K083163

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CAW 2009-09-04

YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K number K083559

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CAW 2009-07-24

JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000

Applicant Danyang Jumao Healthcare Equipment Co., Ltd.

K number K090007

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CAW 2009-07-23

OMNI 5 TOTAL O2 DELIVERY SYSTEM

Applicant Respironics, Inc.

K number K091028

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CAW 2009-05-21

INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100

Applicant Invacare Corporation

K number K083751

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CAW 2008-12-03

MARK 5 NUVO LITE OCSI AND STD

Applicant Nidek Medical Products, Inc.

K number K082566

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CAW 2008-10-27

PRECISION OXYGEN CONCENTRATOR

Applicant Precision Medical, Inc.

K number K072348

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CAW 2008-09-23

HYGEIA-5 OXYGEN CONCENTRATOR

Applicant Kedl Internation Limited

K number K081267

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CAW 2008-08-27

HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN

Applicant Shenyang Canta Medical Tech. Co., Ltd.

K number K081508

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CAW 2008-08-25

DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES

Applicant Sunrise Medical

K number K081468

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CAW 2008-07-28

HOMELOX

Applicant Respironics, Inc.

K number K081206

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CAW 2008-04-16

OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS

Applicant Oxlife, LLC

K number K080082

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CAW 2008-03-18

DRIVE SOLSTICE OXYGEN CONCENTRATOR

Applicant Medical Depot

K number K080391

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CAW 2008-01-11

LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000

Applicant International Biophysics Corp.

K number K072688

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CAW 2008-01-11

A&J POCA01 OXYGEN CONCENTRATOR

Applicant Zhongshan A&J Medical Equipment Co., Ltd.

K number K071608

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CAW 2008-01-03

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400

Applicant Delphi Medical Systems

K number K073242

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CAW 2007-12-12

THE INVACARE FLYER, MODEL IPC 100

Applicant Invacare Corp.

K number K071928

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CAW 2007-10-25

DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)

Applicant Carleton Life Support Systems, Inc.

K number K071904

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CAW 2007-10-01

DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES

Applicant Sunrise Medical

K number K071397

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CAW 2007-08-21

MODEL 300D HOME OXYGEN LIQUEFIER

Applicant Copd Partners, Inc.

K number K071461

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CAW 2007-05-09

POGS, MODEL 33C

Applicant On Site Gas Systems, Inc.

K number K063454

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CAW 2007-01-22

EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD

Applicant Pacific Consolidated Industries, LLC

K number K061414

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CAW 2006-11-21

PORTABLE OXYGEN GENERATOR SYSTEM

Applicant Molecular Products , Ltd.

K number K062153

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CAW 2006-06-28

L4 OXYGEN CONCENTRATOR

Applicant Respironics, Inc.

K number K061261

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CAW 2006-05-30

OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5

Applicant Oxlife, LLC

K number K060922

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CAW 2006-05-16

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

Applicant Merits Health Products Co., Ltd.

K number K053230

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CAW 2006-03-23

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

Applicant Merits Health Products Co., Ltd.

K number K053229

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CAW 2006-02-03

DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES

Applicant Sunrise Medical

K number K053240

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CAW 2005-12-09

OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615

Applicant Oxysure Systems, Inc.

K number K052396

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CAW 2005-10-21

EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR

Applicant Emg Technology Co., Ltd.

K number K043520

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CAW 2005-10-18

LONGFEI LFY-I-5 OXYGEN CONCENTRATOR

Applicant Zhejiang Longfei Industrial Co., Ltd.

K number K033405

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CAW 2005-09-27

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

Applicant Carleton Life Support Systems, Inc.

K number K051887

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CAW 2005-08-22

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

Applicant Ox-Gen, Inc.

K number K033863

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