The following data is part of a premarket notification filed by Hyperbaric Technologies, Inc. with the FDA for Gamow Bag, Hyper Oxy, Hyper Oxy P/t, Pressure-cizer.
| Device ID | K001409 |
| 510k Number | K001409 |
| Device Name: | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERBARIC TECHNOLOGIES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden HYPERBARIC TECHNOLOGIES, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-04 |
| Decision Date | 2000-08-02 |