FDA 510(k) K895513, PERRY SV-1 HYPERBARIC VENTILATOR, by Perry Baromedical Services
FDA 510(k) K895513, PERRY SV-1 HYPERBARIC VENTILATOR, by Perry Baromedical Services
| 510(k) Number | K895513 |
| Device Classification Name | Ventilator, Continuous, Facility Use |
| Device Name | PERRY SV-1 HYPERBARIC VENTILATOR |
| Applicant | Perry Baromedical Services 7555 Garden Rd. Suite B Riviera Beach, FL 33404 |
| Regulation Number | 868.5895 |
| Classification Product Code | CBK |
| Date Received | 09/12/1989 |
| Decision Date | 12/19/1990 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Anesthesiology |
| 510k Review Panel | Anesthesiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 157 |
| Redacted Pages | 65 |
| Unredacted Pages | 92 |
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