510(k) K946349 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
STENODOC
| Applicant | Specs USA, Inc., Sarasota FL, US |
| Decision | Substantially Equivalent, May 24, 1996 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946349
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.