The following data is part of a premarket notification filed by Gulf Coast Hyperbarics, Inc. with the FDA for Multiplace Hyperbaric Treatment Chamber System.
| Device ID | K950957 |
| 510k Number | K950957 |
| Device Name: | MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM |
| Classification | Chamber, Hyperbaric |
| Applicant | GULF COAST HYPERBARICS, INC. 4309 GREEN LEAF CIRCLE Panama City, FL 32404 |
| Contact | James W Mccarthy |
| Correspondent | James W Mccarthy GULF COAST HYPERBARICS, INC. 4309 GREEN LEAF CIRCLE Panama City, FL 32404 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-02 |
| Decision Date | 1995-06-02 |