The following data is part of a premarket notification filed by Perry Baromedical Services with the FDA for Sigma Plus/ Ii Multiplace Hyperbaric System.
| Device ID | K983648 |
| 510k Number | K983648 |
| Device Name: | SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL SERVICES 7555 GARDEN RD. SUITE B Riviera Beach, FL 33404 |
| Contact | Wayne C Mccullogh |
| Correspondent | Wayne C Mccullogh 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 | 1998-10-16 |
| Decision Date | 1999-02-24 |
| Summary: | summary |