The following data is part of a premarket notification filed by Gulf Coast Hyperbarics, Inc. with the FDA for Rectangular Multiplace Hyperbaric Chamber.
| Device ID | K082455 |
| 510k Number | K082455 |
| Device Name: | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | GULF COAST HYPERBARICS, INC. 1100 WEST 26TH ST. Lynn Haven, FL 32444 |
| Contact | James W Mccarthy |
| Correspondent | James W Mccarthy GULF COAST HYPERBARICS, INC. 1100 WEST 26TH ST. Lynn Haven, FL 32444 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2009-05-22 |
| Summary: | summary |