CBF — Chamber, Hyperbaric Class II
FDA product code CBF covers "Chamber, Hyperbaric", a Class II medical device regulated under 21 CFR 868.5470. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CBF
- Device Class
- Class II
- Regulation Number
- 868.5470
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240569 | fink engineering pty | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | November 21, 2024 |
| K220290 | us hyperbaric network | Revitalair 430+ | May 4, 2023 |
| K171899 | oxavita | Revitalair 430F | November 22, 2019 |
| K163109 | oxyheal medical systems | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | March 22, 2017 |
| K152223 | oxyheal medical systems | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen | April 29, 2016 |
| K140559 | sechrist industries | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | May 30, 2014 |
| K102831 | reimers systems | RSI 4200 | August 19, 2011 |
| K092991 | environmental tectonics | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | August 13, 2010 |
| K101262 | pressure-tech | FLEXI-LITE | June 10, 2010 |
| K100268 | sechrist industries | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | April 26, 2010 |
| K082455 | gulf coast hyperbarics | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | May 22, 2009 |
| K081506 | hyperbaric america | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | July 25, 2008 |
| K072427 | perry baromedical | SIGMA SERIES HYPERBARIC CHAMBER | June 11, 2008 |
| K072757 | summit to sea | DIVE AND SHALLOW AND GRAND DIVE | February 8, 2008 |
| K060739 | khrunichev state research and production space centr | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | July 21, 2006 |
| K053498 | wjo | HYPEROX 101 | March 15, 2006 |
| K052866 | oxyheal health group | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | December 13, 2005 |
| K051759 | performance hyperbarics | FLEXI-LITE, MODEL FL-V1.2 | November 17, 2005 |
| K052713 | sechrist industries | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | October 28, 2005 |
| K040145 | ata hyperbaric chamber manufacturing | ATA HCM MONOPLACE HYPERBARIC SYSTEM | May 4, 2005 |