The following data is part of a premarket notification filed by Oxyheal Health Group with the FDA for Oxyheal 1000 Monoplace Hyperbaric Chamber.
| Device ID | K052866 |
| 510k Number | K052866 |
| Device Name: | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | OXYHEAL HEALTH GROUP 3224 HOOVER AVE. National City, CA 91950 |
| Contact | Dave Heany |
| Correspondent | Dave Heany OXYHEAL HEALTH GROUP 3224 HOOVER AVE. National City, CA 91950 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006478964 | K052866 | 000 |