510(k) K061755 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
| Applicant | Esaote Europe B.V., Carmel IN, US |
| Decision | Substantially Equivalent, Aug 7, 2006 |
| Received | Jun 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061755
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.