FDA 510(k) Applications for Medical Device Product Code "CBF"
(Chamber, Hyperbaric)

FDA 510(k) Number Applicant Device Name Decision Date
K011592 AMRON INTERNATIONAL DIVING SUPPLY, INC. OXYGEN TREATMENT HOOD 06/19/2002
K040145 ATA HYPERBARIC CHAMBER MANUFACTURING ATA HCM MONOPLACE HYPERBARIC SYSTEM 05/04/2005
K030713 BAY AREA HYPERSCIENCES, LLC BAY AREA HYPERSCIENCES 12/19/2003
K842303 BIOCHEM INTERNATIONAL, INC. MICROSPAN -PH MONITOR 10/12/1984
K841608 CUSTOM CRAFT PRODUCTS, INC. MODEL 3000 HYPERBARIC CHAMBER 05/02/1984
K861315 CUTTER LABORATORIES, INC. HYPERBARIC PENETRATION EXTENSION SET 05/21/1986
K001121 ENGINEERED MEDICAL TECHNOLOGY, INC. OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) 11/29/2001
K020974 ENVIRONMENTAL TECTONICS CORP. BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER 06/26/2002
K993010 ENVIRONMENTAL TECTONICS CORP. BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER 05/30/2000
K092991 ENVIRONMENTAL TECTONICS CORP. O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) 08/13/2010
K031649 FINK ENGINEERING PTY LTD SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES 12/05/2003
K011565 GULF COAST HYPERBARICS, INC. INFANT OXYGEN TREATMENT HOOD 08/16/2001
K950957 GULF COAST HYPERBARICS, INC. MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM 06/02/1995
K082455 GULF COAST HYPERBARICS, INC. RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER 05/22/2009
K874107 HYOX SYSTEMS C/O MECHIDYNE SYSTEMS, INC. H.T.U. (HYPERBARIC THERAPY UNIT) 12/07/1987
K984313 HYOX SYSTEMS LTD. HTU3 10/22/1999
K874752 HYPERBARIC AEROBICS, LTD. GAMOW HYPERBARIC BAG 02/02/1988
K081506 HYPERBARIC AMERICA, LLC HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS 07/25/2008
K041007 HYPERBARIC FOR LIFE LLC MILLENIUM, MODELS 2000, 2001 AND 2002 11/15/2004
K790693 HYPERBARIC OXYGEN THERAPY, INC. HYPERBARIC OXYGEN CHAMBER 07/30/1979
K001409 HYPERBARIC TECHNOLOGIES, INC. GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER 08/02/2000
K011866 HYPERBARIC TECHNOLOGIES, INC. OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES 06/06/2002
K002794 HYPERTEC, INC. MODEL 5000 MULTIPLACE HYPERBARIC THERAPY 12/06/2000
K002795 HYPERTEC, INC. MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS 12/06/2000
K011312 KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM 07/18/2001
K060739 KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 07/21/2006
K955535 LOUISVILLE LABORATORIES, INC. LOUISVILLE LABS OXYGEN HEAD TENT 07/01/1996
K030418 MAKAI MARINE INDUSTRIES, INC. MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM 01/29/2004
K022214 MECHIDYNE SYSTEMS, INC. MSI I2010 DUAL PLACE HYPERBARIC CHAMBER 02/26/2003
K933929 MIGADA, LTD. LAB-SITE(R) SAFETY CANNULA 12/07/1993
K832127 NAUTILUS ENVIRONMEDICAL SYSTEMS, INC. NAUTILUS MONOPLACE HYPERBARIC UNIT 08/12/1983
K850563 NAUTILUS ENVIRONMEDICAL SYSTEMS, INC. SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION 03/12/1985
K951044 NTH SYSTEMS, INC. SYSTEM ONE HYPERBARIC CHAMBER 01/25/1996
K052866 OXYHEAL HEALTH GROUP OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER 12/13/2005
K163109 OXYHEAL MEDICAL SYSTEMS, INC. OxyHeal 4000 Multiplace Hyperbaric Chamber Family 03/22/2017
K152223 OXYHEAL MEDICAL SYSTEMS, INC. Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System 04/29/2016
K021690 PAN-AMERICA HYPERBARICS, INC. PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 10/24/2002
K021693 PAN-AMERICA HYPERBARICS, INC. PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 10/24/2002
K021689 PAN-AMERICA HYPERBARICS, INC. PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 10/24/2002
K051759 PERFORMANCE HYPERBARICS FLEXI-LITE, MODEL FL-V1.2 11/17/2005
K990927 PERRY BAROMEDICAL CORP. SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER 11/12/1999
K974868 PERRY BAROMEDICAL CORP. SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER 07/02/1998
K072427 PERRY BAROMEDICAL CORP. SIGMA SERIES HYPERBARIC CHAMBER 06/11/2008
K862198 PERRY BAROMEDICAL SERVICES SIGMA II - DUAL PLACE HYPERBARIC CHAMBER 11/12/1986
K930748 PERRY BAROMEDICAL SERVICES SIGMA MP MULTIPLACE HYPERBARIC CHAMBER 08/20/1993
K983648 PERRY BAROMEDICAL SERVICES SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM 02/24/1999
K101262 PRESSURE-TECH, INC. FLEXI-LITE 06/10/2010
K962869 REIMERS SYSTEMS, INC. GSP1 - GAS SELECTION PANEL 10/23/1996
K951125 REIMERS SYSTEMS, INC. LIFEFORCE CLINICAL HYPERBARIC FACILITY 06/02/1995
K962871 REIMERS SYSTEMS, INC. ODS1 - HOOD DRIVER 10/23/1996
K102831 REIMERS SYSTEMS, INC. RSI 4200 08/19/2011
K954387 REIMERS SYSTEMS, INC. T CLASS HYPERBARIC FACILITIES 12/15/1995
K840841 RENEAU, INC. RENEAU UNIT 08/07/1984
K905168 S.O.S. LTD. HYPERLITE 07/22/1991
K972908 SANDS HYPERBARICS SANDS SERIES III HYPERBARIC CHAMBER 07/22/1998
K010659 SEA-LONG MEDICAL SYSTEMS, INC. SEA-LONG MEDICAL TREATMENT HOOD 05/16/2001
K934164 SECHRIST INDUSTRIES, INC. MODEL 2500E/2500ER HYPERBARIC CHAMBER 06/13/1995
K950386 SECHRIST INDUSTRIES, INC. MODEL 3200P/3200PR HYPERBARIC CHAMBER 06/13/1995
K052713 SECHRIST INDUSTRIES, INC. MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER 10/28/2005
K100268 SECHRIST INDUSTRIES, INC. SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER 04/26/2010
K140559 SECHRIST INDUSTRIES, INC. SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER 05/30/2014
K072757 SUMMIT TO SEA DIVE AND SHALLOW AND GRAND DIVE 02/08/2008
K960389 TAMPA HYPERBARIC ENT. HYPERBARIC CHAMBER 12/05/1996
K981938 TAMPA HYPERBARIC ENT. TAMPA HYPERBARIC MONOPLACE CHAMBER 07/06/1999
K053498 WJO, INC HYPEROX 101 03/15/2006
K952545 WRIGHT INDUSTRIES WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM 05/28/1997


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