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 |
| 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 |
| K082455 | GULF COAST HYPERBARICS, INC. | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | 05/22/2009 |
| K984313 | HYOX SYSTEMS LTD. | HTU3 | 10/22/1999 |
| 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 |
| 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 |
| K951044 | NTH SYSTEMS, INC. | SYSTEM ONE HYPERBARIC CHAMBER | 01/25/1996 |
| K171899 | Oxavita S.R.L. | Revitalair 430F | 11/22/2019 |
| 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 |
| 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 |
| K962871 | REIMERS SYSTEMS, INC. | ODS1 - HOOD DRIVER | 10/23/1996 |
| K102831 | REIMERS SYSTEMS, INC. | RSI 4200 | 08/19/2011 |
| 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 |
| 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 |
| K220290 | US Hyperbaric Network | Revitalair 430+ | 05/04/2023 |
| K053498 | WJO, INC | HYPEROX 101 | 03/15/2006 |
| K952545 | WRIGHT INDUSTRIES | WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM | 05/28/1997 |
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