The following data is part of a premarket notification filed by Tampa Hyperbaric Ent. with the FDA for Tampa Hyperbaric Monoplace Chamber.
| Device ID | K981938 |
| 510k Number | K981938 |
| Device Name: | TAMPA HYPERBARIC MONOPLACE CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | TAMPA HYPERBARIC ENT. 700 WEST WATERS AVE. Tampa, FL 33604 |
| Contact | Michael Capria |
| Correspondent | Michael Capria TAMPA HYPERBARIC ENT. 700 WEST WATERS AVE. Tampa, FL 33604 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-02 |
| Decision Date | 1999-07-06 |
| Summary: | summary |