Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Chamber, Hyperbaric

FDA product code CBF · 68 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5470
Review panel: AN
Implant: No
Life sustaining: Yes
Third party review: Yes
GMP exempt: No
Clearance span: 1979-07-30 – 2024-11-21

CBF 2024-11-21

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

Applicant Fink Engineering Pty, Ltd.

K number K240569

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CBF 2023-05-04

Revitalair 430+

Applicant Us Hyperbaric Network

K number K220290

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CBF 2019-11-22

Revitalair 430F

Applicant Oxavita Srl

K number K171899

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CBF 2017-03-22

OxyHeal 4000 Multiplace Hyperbaric Chamber Family

Applicant Oxyheal Medical Systems, Inc.

K number K163109

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CBF 2016-04-29

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

Applicant Oxyheal Medical Systems, Inc.

K number K152223

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CBF 2011-08-19

RSI 4200

Applicant Reimers Systems, Inc.

K number K102831

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CBF 2010-08-13

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)

Applicant Environmental Tectonics Corp.

K number K092991

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CBF 2010-06-10

FLEXI-LITE

Applicant Pressure-Tech, Inc.

K number K101262

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CBF 2010-04-26

SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER

Applicant Sechrist Industries, Inc.

K number K100268

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CBF 2009-05-22

RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER

Applicant Gulf Coast Hyperbarics, Inc.

K number K082455

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CBF 2008-07-25

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS

Applicant Hyperbaric America, LLC

K number K081506

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CBF 2008-06-11

SIGMA SERIES HYPERBARIC CHAMBER

Applicant Perry Baromedical Corp.

K number K072427

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CBF 2008-02-08

DIVE AND SHALLOW AND GRAND DIVE

Applicant Summit TO Sea

K number K072757

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CBF 2006-07-21

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307

Applicant Khrunichev State Research & Production Space Centr

K number K060739

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CBF 2006-03-15

HYPEROX 101

Applicant Wjo, Inc.

K number K053498

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CBF 2005-12-13

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER

Applicant Oxyheal Health Group

K number K052866

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CBF 2005-11-17

FLEXI-LITE, MODEL FL-V1.2

Applicant Performance Hyperbarics

K number K051759

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CBF 2005-10-28

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER

Applicant Sechrist Industries, Inc.

K number K052713

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CBF 2005-05-04

ATA HCM MONOPLACE HYPERBARIC SYSTEM

Applicant Ata Hyperbaric Chamber Manufacturing

K number K040145

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CBF 2004-11-15

MILLENIUM, MODELS 2000, 2001 AND 2002

Applicant Hyperbaric For Life, LLC

K number K041007

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CBF 2004-01-29

MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM

Applicant Makai Marine Industries, Inc.

K number K030418

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CBF 2003-12-19

BAY AREA HYPERSCIENCES

Applicant Bay Area Hypersciences, LLC

K number K030713

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CBF 2003-12-05

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

Applicant Fink Engineering Pty, Ltd.

K number K031649

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CBF 2003-02-26

MSI I2010 DUAL PLACE HYPERBARIC CHAMBER

Applicant Mechidyne Systems, Inc.

K number K022214

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CBF 2002-10-24

PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1

Applicant Pan-America Hyperbarics, Inc.

K number K021693

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CBF 2002-10-24

PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1

Applicant Pan-America Hyperbarics, Inc.

K number K021690

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CBF 2002-10-24

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2

Applicant Pan-America Hyperbarics, Inc.

K number K021689

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CBF 2002-06-26

BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER

Applicant Environmental Tectonics Corp.

K number K020974

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CBF 2002-06-19

OXYGEN TREATMENT HOOD

Applicant Amron International Diving Supply, Inc.

K number K011592

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CBF 2002-06-06

OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES

Applicant Hyperbaric Technologies, Inc.

K number K011866

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CBF 2001-11-29

OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

Applicant Engineered Medical Technology, Inc.

K number K001121

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CBF 2001-08-16

INFANT OXYGEN TREATMENT HOOD

Applicant Gulf Coast Hyperbarics, Inc.

K number K011565

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CBF 2001-07-18

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

Applicant Khrunichev State Research & Production Space Centr

K number K011312

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CBF 2001-05-16

SEA-LONG MEDICAL TREATMENT HOOD

Applicant Sea-Long Medical Systems, Inc.

K number K010659

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CBF 2000-12-06

MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

Applicant Hypertec, Inc.

K number K002795

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CBF 2000-12-06

MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

Applicant Hypertec, Inc.

K number K002794

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CBF 2000-08-02

GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER

Applicant Hyperbaric Technologies, Inc.

K number K001409

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CBF 2000-05-30

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER

Applicant Environmental Tectonics Corp.

K number K993010

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CBF 1999-11-12

SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

Applicant Perry Baromedical Corp.

K number K990927

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CBF 1999-10-22

HTU3

Applicant Hyox Systems , Ltd.

K number K984313

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CBF 1999-07-06

TAMPA HYPERBARIC MONOPLACE CHAMBER

Applicant Tampa Hyperbaric Ent.

K number K981938

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CBF 1999-02-24

SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM

Applicant Perry Baromedical Services

K number K983648

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CBF 1998-07-22

SANDS SERIES III HYPERBARIC CHAMBER

Applicant Sands Hyperbarics

K number K972908

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CBF 1998-07-02

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER

Applicant Perry Baromedical Corp.

K number K974868

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CBF 1997-05-28

WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM

Applicant Wright Industries

K number K952545

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CBF 1996-12-05

HYPERBARIC CHAMBER

Applicant Tampa Hyperbaric Ent.

K number K960389

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CBF 1996-10-23

ODS1 - HOOD DRIVER

Applicant Reimers Systems, Inc.

K number K962871

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CBF 1996-10-23

GSP1 - GAS SELECTION PANEL

Applicant Reimers Systems, Inc.

K number K962869

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CBF 1996-07-01

LOUISVILLE LABS OXYGEN HEAD TENT

Applicant Louisville Laboratories, Inc.

K number K955535

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CBF 1996-01-25

SYSTEM ONE HYPERBARIC CHAMBER

Applicant Nth Systems, Inc.

K number K951044

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CBF 1995-12-15

T CLASS HYPERBARIC FACILITIES

Applicant Reimers Systems, Inc.

K number K954387

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CBF 1995-06-13

MODEL 3200P/3200PR HYPERBARIC CHAMBER

Applicant Sechrist Industries, Inc.

K number K950386

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CBF 1995-06-13

MODEL 2500E/2500ER HYPERBARIC CHAMBER

Applicant Sechrist Industries, Inc.

K number K934164

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CBF 1995-06-02

LIFEFORCE CLINICAL HYPERBARIC FACILITY

Applicant Reimers Systems, Inc.

K number K951125

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CBF 1995-06-02

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM

Applicant Gulf Coast Hyperbarics, Inc.

K number K950957

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CBF 1993-12-07

LAB-SITE(R) SAFETY CANNULA

Applicant Migada, Ltd.

K number K933929

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CBF 1993-08-20

SIGMA MP MULTIPLACE HYPERBARIC CHAMBER

Applicant Perry Baromedical Services

K number K930748

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CBF 1991-07-22

HYPERLITE

Applicant S.O.S. , Ltd.

K number K905168

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CBF 1988-02-02

GAMOW HYPERBARIC BAG

Applicant Hyperbaric Aerobics, Ltd.

K number K874752

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CBF 1987-12-07

H.T.U. (HYPERBARIC THERAPY UNIT)

Applicant Hyox Systems C/O Mechidyne Systems, Inc.

K number K874107

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CBF 1986-11-12

SIGMA II - DUAL PLACE HYPERBARIC CHAMBER

Applicant Perry Baromedical Services

K number K862198

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CBF 1986-05-21

HYPERBARIC PENETRATION EXTENSION SET

Applicant Cutter Laboratories, Inc.

K number K861315

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CBF 1985-03-12

SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION

Applicant Nautilus Environmedical Systems, Inc.

K number K850563

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CBF 1984-10-12

MICROSPAN -PH MONITOR

Applicant Biochem International, Inc.

K number K842303

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CBF 1984-08-07

RENEAU UNIT

Applicant Reneau, Inc.

K number K840841

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CBF 1984-05-02

MODEL 3000 HYPERBARIC CHAMBER

Applicant Custom Craft Products, Inc.

K number K841608

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CBF 1983-08-12

NAUTILUS MONOPLACE HYPERBARIC UNIT

Applicant Nautilus Environmedical Systems, Inc.

K number K832127

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CBF 1979-07-30

HYPERBARIC OXYGEN CHAMBER

Applicant Hyperbaric Oxygen Therapy, Inc.

K number K790693

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