FDA 510(k) K974868, SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER, by Perry Baromedical Corp.
FDA 510(k) K974868, SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER, by Perry Baromedical Corp.
| 510(k) Number | K974868 |
| Device Classification Name | Chamber, Hyperbaric |
| Device Name | SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER |
| Applicant | Perry Baromedical Corp. 7555 Garden Rd. Riviera Beach, FL 33404 |
| Regulation Number | 868.547 |
| Classification Product Code | CBF |
| Date Received | 12/29/1997 |
| Decision Date | 07/02/1998 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Anesthesiology |
| 510k Review Panel | Anesthesiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 139 |
| Redacted Pages | 20 |
| Unredacted Pages | 119 |
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