Meter, Peak Flow, Spirometry

FDA product code BZH · 80 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1860
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-04 – 2026-06-23

BZH 2026-06-23

Microlife Digital Peak Flow Meter, Model PF200B (PF200B)

Applicant Microlife Corporation

K number K253180

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BZH 2026-05-29

Peak Flow Meter (PF-10(BR-PEF231))

Applicant Shenzhen Bi-Rich Medical Devices Co., Ltd.

K number K252802

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BZH 2024-12-31

Peak Flow Meter

Applicant Chongqing Moffy Innovation Technology Co., Ltd.

K number K241338

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BZH 2024-11-25

Aluna 2

Applicant Knox Medical Diagnostics

K number K232588

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BZH 2024-02-23

Electronic Peak Flow Meter

Applicant Taian Dalu Medical Instrument Co., Ltd.

K number K230423

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BZH 2023-12-19

TD-7301 Peak Flow meter

Applicant Gostar Co., Ltd.

K number K222810

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BZH 2021-05-26

Peak flow meter

Applicant Shanghai Sonmol Medical Equipment Co., Ltd.

K number K203196

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BZH 2020-07-30

Safey Peak Flow Meter

Applicant Safey Medical Devices Pvt, Ltd.

K number K200832

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BZH 2020-03-25

Aluna

Applicant Knox Medical Diagnostics, Inc.

K number K193311

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BZH 2019-12-06

Smart Peak Flow Meter

Applicant Guangzhou Homesun Medical Technology Co., Ltd.

K number K191239

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BZH 2018-10-26

Peak.me

Applicant Breathe Me, Ltd.

K number K180487

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BZH 2018-08-01

Smart One

Applicant Mir Medical International Research

K number K181666

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BZH 2018-01-11

Besmed Peak Flow Meter

Applicant Besmed Health Business Corp

K number K172804

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BZH 2017-10-06

MSA100BT Peak Flow Meter

Applicant Beijing M&B Electronic Instruments Co., Ltd.

K number K170281

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BZH 2016-06-03

Wing Smart FEVI and Peak Flow Meter

Applicant Sparo, Inc.

K number K152276

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BZH 2013-04-17

STRIVE DUAL ZONE PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K123945

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BZH 2010-09-13

RXPEAKFLOW

Applicant Noble Marketing

K number K101380

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BZH 2010-04-09

PEAK EXPIRATORY FLOW METER, KN-9710

Applicant K-Jump Health Co., Ltd.

K number K092335

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BZH 2009-08-21

CLEAN PEAK FLOW METER

Applicant Viasys Healthcare GmbH

K number K091412

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BZH 2009-03-10

DYNAMIPEAK PEAK FLOW METER

Applicant Dynamitech Medical, Inc.

K number K082899

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BZH 2006-01-31

MINI-WRIGHT DIGITAL, MODEL 3120001

Applicant Clement Clarke Intl., Ltd.

K number K053156

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BZH 2005-05-04

PMP4 SPIROPRO

Applicant Card Guard Scientific Survival , Ltd.

K number K050853

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BZH 2004-06-10

MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)

Applicant Microlife Intellectual Property GmbH

K number K040723

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BZH 2003-11-14

MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100

Applicant Microlife Corp.

K number K031024

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BZH 2003-08-27

MICROPEAK

Applicant Micro Direct, Inc.

K number K030586

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BZH 2003-05-23

MODIFICATION TO TRUPEAK PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K031514

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BZH 2003-04-03

GALEMED PEAK FLOW METER, MODELS 3751/3752

Applicant Galemed Corp.

K number K022124

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BZH 2003-03-07

TRUEZONE PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K023097

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BZH 2001-11-29

KP + LFM

Applicant Pds Healthcare Products, Inc.

K number K013489

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BZH 2001-06-01

KOKO PEAK KP; KOKO PEAK KP+

Applicant Pds Healthcare Products, Inc.

K number K010009

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BZH 2000-02-25

ONEFLOW

Applicant Sti Medical

K number K980951

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BZH 2000-02-04

VITALOGRAPH MICRO

Applicant Vitalograph, Inc.

K number K991412

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BZH 1999-10-29

RESPALERT

Applicant Harwill Medical (Pty) , Ltd.

K number K992618

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BZH 1999-07-01

MODIFICATION TO TRUZONE PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K991212

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BZH 1999-01-14

AIRZONE PEAK FLOWMETER

Applicant Clement Clarke Intl., Ltd.

K number K982334

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BZH 1998-12-04

ACCUTRAX, MODEL EPF840

Applicant Korr Medical Technologies, Inc.

K number K982995

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BZH 1998-10-29

AIRWATCH II ZONE

Applicant Enact Health Management Systems

K number K982676

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BZH 1998-10-29

AIRWATCH II ZONELESS

Applicant Enact Health Management Systems

K number K982675

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BZH 1998-08-27

WHISTLE WATCH

Applicant Harwill Medical (Pty) , Ltd.

K number K980550

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BZH 1998-06-10

IN-CHECK INSPIRATORY FLOWMETER

Applicant Clement Clarke Intl., Ltd.

K number K980960

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BZH 1998-04-30

PEAK FLOW METER MINIMAX

Applicant The D&T, Inc.

K number K980443

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BZH 1997-06-13

PEAK FLOW METER

Applicant Intl. Medical, Inc.

K number K970507

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BZH 1997-06-13

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER

Applicant Avion Medical Products, Inc.

K number K961779

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BZH 1997-01-10

AEROGEAR ASTHMA ACTION KIT

Applicant Monaghan Medical Corp.

K number K964130

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BZH 1997-01-02

VM PLUS PEAK FLOWMETER

Applicant Clement Clarke Intl., Ltd.

K number K962074

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BZH 1996-11-06

TRUZONE PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K963089

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BZH 1996-11-04

TRUPEAK PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K963095

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BZH 1996-10-25

PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM

Applicant Healthscan Products, Inc.

K number K962924

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BZH 1996-10-24

PERSONAL BEST II

Applicant Healthscan Products, Inc.

K number K962929

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BZH 1996-06-13

BREATH-TAKER BREATH-ALERT

Applicant Roxon - Universal Medical , Ltd.

K number K953411

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BZH 1996-03-29

AUTOZONE

Applicant Health Scan, Inc.

K number K952909

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BZH 1996-03-29

MINI WRIGHT LR AFS

Applicant Clement Clarke, Inc.

K number K952713

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BZH 1996-03-18

TRUPEAK PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K955234

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BZH 1996-03-07

TRUZONE PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K955262

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BZH 1996-02-21

ASTECH PEAK FLOW METER

Applicant Center Laboratories, Inc.

K number K954277

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BZH 1995-12-14

ELECTRONIC FLOW METER

Applicant Vitalograph, Inc.

K number K943678

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BZH 1995-11-17

RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN

Applicant Raiinbow Step UP Systems, Inc.

K number K953458

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BZH 1995-04-14

CARD GUARD

Applicant Card Guard Scientific Survival , Ltd.

K number K934795

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BZH 1995-03-23

ASPIRE

Applicant Dura Pharmaceuticals, Inc.

K number K936110

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BZH 1994-11-16

AIRWATCH MONITOR

Applicant Enact Health Management Systems

K number K941226

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BZH 1994-11-01

PEAKLOG AND DISPLAY SOFTWARE

Applicant Tamarac Systems Corp.

K number K940836

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BZH 1994-11-01

PEAKLOG AND DISPLAY SOFTWARE

Applicant Medtrac Technologies Corp.

K number K940835

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BZH 1994-04-26

FLOW=MED

Applicant International Electronic Technology Corp.

K number K924322

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BZH 1994-04-04

FLOW SPIROMETER

Applicant Healthdyne, Inc.

K number K934502

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BZH 1993-09-09

PERSONAL BEST LOW RANGE

Applicant Healthscan Products, Inc.

K number K933889

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BZH 1993-07-22

PEAK FLOW METER

Applicant Monaghan Medical Corp.

K number K926307

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BZH 1993-06-16

WRIGHT POCKET PEAK FLOW METER

Applicant Ferraris Medical, Inc.

K number K924343

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BZH 1993-03-05

VMX MINI-LOG FLOWMETER

Applicant Clement Clarke, Inc.

K number K914126

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BZH 1992-09-11

THE PEAK

Applicant Multispiro, Inc.

K number K920390

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BZH 1992-09-11

ASTECH HOME PEAK FLOW METER

Applicant Biotrine Corp.

K number K915060

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BZH 1992-08-13

PEAK EXPIRATORY FLOW METER

Applicant Health Products, Inc.

K number K912866

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BZH 1992-07-27

PEAK FLOW MONITOR

Applicant Spirometrics, Inc.

K number K915059

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BZH 1990-08-10

MODIFIED ASSESS(R) PEAK FLOW METER

Applicant Health Products, Inc.

K number K902292

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BZH 1990-01-30

MODIFIED ASSESS(R) PEAK FLOW METER

Applicant Health Products, Inc.

K number K896953

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BZH 1985-11-14

PLOTTER FOR AS-500

Applicant Riko Medical & Scientific Instrument Corp.

K number K853922

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BZH 1985-10-29

PEAK FLOWMETERS FOR SPIROMETRY

Applicant Solcoor, Inc.

K number K851265

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BZH 1981-12-31

PEAK FLOW MONITOR

Applicant Biotrine Corp.

K number K813414

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BZH 1979-02-13

PULMONARY MONITOR

Applicant Vitalograph , Ltd.

K number K781922

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BZH 1978-10-15

METER, FLOW, PEAK

Applicant Projects IN Health

K number K781224

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BZH 1977-08-04

PEAK FLOW METER

Applicant Projects IN Health

K number K770580

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