The following data is part of a premarket notification filed by Perry Baromedical Services with the FDA for Sigma Mp Multiplace Hyperbaric Chamber.
| Device ID | K930748 |
| 510k Number | K930748 |
| Device Name: | SIGMA MP MULTIPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL SERVICES 7555 GARDEN RD. SUITE B Riviera Beach, FL 33404 |
| Contact | Dennis J Holstein |
| Correspondent | Dennis J Holstein PERRY BAROMEDICAL SERVICES 7555 GARDEN RD. SUITE B Riviera Beach, FL 33404 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-08-20 |