Submission Details
| 510(k) Number | K872291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1987 |
| Decision Date | September 25, 1987 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |