Submission Details
| 510(k) Number | K940919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 24, 1994 |
| Decision Date | February 03, 1995 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |