The following data is part of a premarket notification filed by Perry Baromedical Corp. with the FDA for Sigma 3400 Monoplace Hyperbaric Chamber.
| Device ID | K990927 |
| 510k Number | K990927 |
| Device Name: | SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Rivera Beach, FL 33404 |
| Contact | James P Dodson |
| Correspondent | James P Dodson PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Rivera 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 | 1999-03-19 |
| Decision Date | 1999-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852678007108 | K990927 | 000 |
| 00852678007092 | K990927 | 000 |
| 00852678007085 | K990927 | 000 |
| 00852678007030 | K990927 | 000 |
| 00852678007023 | K990927 | 000 |
| 00852678007016 | K990927 | 000 |