Submission Details
| 510(k) Number | K780085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1978 |
| Decision Date | January 30, 1978 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |