510(k) K101605 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLABONE ULTRASOUND SYSTEM
| Applicant | Esaote Europe B.V., Carmel IN, US |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | Jun 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101605
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.