Panels › Anesthesiology › Product code CBF · Class 2
Chamber, Hyperbaric
Regulation 868.5470
0510(k)s in 12 months (69 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in CBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Sechrist Industries, Inc. | 5 | 2 |
| Reimers Systems, Inc. | 5 | 0 |
| Environmental Tectonics Corp. | 3 | 0 |
| Gulf Coast Hyperbarics, Inc. | 3 | 0 |
| Pan-America Hyperbarics, Inc. | 3 | 0 |
| Perry Baromedical Corp. | 3 | 0 |
| Perry Baromedical Services | 3 | 0 |
| Fink Engineering Pty, Ltd. | 2 | 0 |
| Hyperbaric Technologies, Inc. | 2 | 0 |
| Hypertec, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2024 | K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber Fink Engineering Pty, Ltd., AU | CBF |
| May 4, 2023 | K220290 | Revitalair 430+ Us Hyperbaric Network | CBF |
| Nov 22, 2019 | K171899 | Revitalair 430F Oxavita Srl, AR | CBF |
| Mar 22, 2017 | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family Oxyheal Medical Systems, Inc. | CBF |
| Apr 29, 2016 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System Oxyheal Medical Systems, Inc. | CBF |
| May 30, 2014 | K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER Sechrist Industries, Inc. | CBF |
| Aug 19, 2011 | K102831 | RSI 4200 Reimers Systems, Inc. | CBF |
| Aug 13, 2010 | K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) Environmental Tectonics Corp. | CBF |
| Jun 10, 2010 | K101262 | FLEXI-LITE Pressure-Tech, Inc. | CBF |
| Apr 26, 2010 | K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER Sechrist Industries, Inc. | CBF |
| May 22, 2009 | K082455 | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER Gulf Coast Hyperbarics, Inc. | CBF |
| Jul 25, 2008 | K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS Hyperbaric America, LLC | CBF |
| Jun 11, 2008 | K072427 | SIGMA SERIES HYPERBARIC CHAMBER Perry Baromedical Corp. | CBF |
| Feb 8, 2008 | K072757 | DIVE AND SHALLOW AND GRAND DIVE Summit TO Sea | CBF |
| Jul 21, 2006 | K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 Khrunichev State Research & Production Space Centr | CBF |
| Mar 15, 2006 | K053498 | HYPEROX 101 Wjo, Inc. | CBF |
| Dec 13, 2005 | K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER Oxyheal Health Group | CBF |
| Nov 17, 2005 | K051759 | FLEXI-LITE, MODEL FL-V1.2 Performance Hyperbarics | CBF |
| Oct 28, 2005 | K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER Sechrist Industries, Inc. | CBF |
| May 4, 2005 | K040145 | ATA HCM MONOPLACE HYPERBARIC SYSTEM Ata Hyperbaric Chamber Manufacturing, CA | CBF |
| Nov 15, 2004 | K041007 | MILLENIUM, MODELS 2000, 2001 AND 2002 Hyperbaric For Life, LLC | CBF |
| Jan 29, 2004 | K030418 | MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM Makai Marine Industries, Inc. | CBF |
| Dec 19, 2003 | K030713 | BAY AREA HYPERSCIENCES Bay Area Hypersciences, LLC | CBF |
| Dec 5, 2003 | K031649 | SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES Fink Engineering Pty, Ltd. | CBF |
| Feb 26, 2003 | K022214 | MSI I2010 DUAL PLACE HYPERBARIC CHAMBER Mechidyne Systems, Inc. | CBF |
| Oct 24, 2002 | K021693 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 Pan-America Hyperbarics, Inc. | CBF |
| Oct 24, 2002 | K021690 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 Pan-America Hyperbarics, Inc. | CBF |
| Oct 24, 2002 | K021689 | PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 Pan-America Hyperbarics, Inc. | CBF |
| Jun 26, 2002 | K020974 | BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER Environmental Tectonics Corp. | CBF |
| Jun 19, 2002 | K011592 | OXYGEN TREATMENT HOOD Amron International Diving Supply, Inc. | CBF |
| Jun 6, 2002 | K011866 | OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES Hyperbaric Technologies, Inc. | CBF |
| Nov 29, 2001 | K001121 | OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) Engineered Medical Technology, Inc. | CBF |
| Aug 16, 2001 | K011565 | INFANT OXYGEN TREATMENT HOOD Gulf Coast Hyperbarics, Inc. | CBF |
| Jul 18, 2001 | K011312 | BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM Khrunichev State Research & Production Space Centr | CBF |
| May 16, 2001 | K010659 | SEA-LONG MEDICAL TREATMENT HOOD Sea-Long Medical Systems, Inc. | CBF |
| Dec 6, 2000 | K002795 | MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS Hypertec, Inc. | CBF |
| Dec 6, 2000 | K002794 | MODEL 5000 MULTIPLACE HYPERBARIC THERAPY Hypertec, Inc. | CBF |
| Aug 2, 2000 | K001409 | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER Hyperbaric Technologies, Inc. | CBF |
| May 30, 2000 | K993010 | BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER Environmental Tectonics Corp. | CBF |
| Nov 12, 1999 | K990927 | SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER Perry Baromedical Corp. | CBF |
| Oct 22, 1999 | K984313 | HTU3 Hyox Systems , Ltd. | CBF |
| Jul 6, 1999 | K981938 | TAMPA HYPERBARIC MONOPLACE CHAMBER Tampa Hyperbaric Ent. | CBF |
| Feb 24, 1999 | K983648 | SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM Perry Baromedical Services | CBF |
| Jul 22, 1998 | K972908 | SANDS SERIES III HYPERBARIC CHAMBER Sands Hyperbarics | CBF |
| Jul 2, 1998 | K974868 | SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER Perry Baromedical Corp. | CBF |
| May 28, 1997 | K952545 | WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM Wright Industries | CBF |
| Dec 5, 1996 | K960389 | HYPERBARIC CHAMBER Tampa Hyperbaric Ent. | CBF |
| Oct 23, 1996 | K962871 | ODS1 - HOOD DRIVER Reimers Systems, Inc. | CBF |
| Oct 23, 1996 | K962869 | GSP1 - GAS SELECTION PANEL Reimers Systems, Inc. | CBF |
| Jul 1, 1996 | K955535 | LOUISVILLE LABS OXYGEN HEAD TENT Louisville Laboratories, Inc. | CBF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.