Submission Details
| 510(k) Number | K944024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1994 |
| Decision Date | December 08, 1994 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |