Submission Details
| 510(k) Number | K926174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1992 |
| Decision Date | October 25, 1993 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |