510(k) K840367 ยท DSP System, Balloon, Intra-Aortic And Control
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
| Applicant | Smec, Inc. TN, US |
| Decision | Substantially Equivalent, Dec 11, 1985 |
| Received | Jan 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840367
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.