The following data is part of a premarket notification filed by Perry Baromedical Services with the FDA for Perry Sv-1 Hyperbaric Ventilator.
| Device ID | K895513 |
| 510k Number | K895513 |
| Device Name: | PERRY SV-1 HYPERBARIC VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PERRY BAROMEDICAL SERVICES 7555 GARDEN RD. SUITE B Riviera Beach, FL 33404 |
| Contact | Donald W Grissett |
| Correspondent | Donald W Grissett PERRY BAROMEDICAL SERVICES 7555 GARDEN RD. SUITE B Riviera Beach, FL 33404 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1990-12-19 |