The following data is part of a premarket notification filed by Hyperbaric Oxygen Therapy, Inc. with the FDA for Hyperbaric Oxygen Chamber.
| Device ID | K790693 |
| 510k Number | K790693 |
| Device Name: | HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERBARIC OXYGEN THERAPY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-10 |
| Decision Date | 1979-07-30 |