510(k) K961116 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
FIRST BEAT/CARDIO BEAT/CALC
| Applicant | Medasonics, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Aug 8, 1996 |
| Received | Mar 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961116
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.