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 |