510(k) K000681 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
AU5, AU6
| Applicant | Biosound Esaote, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 3, 2000 |
| Received | Feb 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000681
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.