The following data is part of a premarket notification filed by Perry Baromedical Corp. with the FDA for Sigma Plus Monoplace Hyperbaric Chamber.
| Device ID | K974868 |
| 510k Number | K974868 |
| Device Name: | SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL CORP. 7555 GARDEN RD. Riviera Beach, FL 33404 |
| Contact | James P Dodson |
| Correspondent | James P Dodson PERRY BAROMEDICAL CORP. 7555 GARDEN RD. 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 | 1997-12-29 |
| Decision Date | 1998-07-02 |
| Summary: | summary |