Submission Details
| 510(k) Number | K924275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1992 |
| Decision Date | July 27, 1993 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |