510(k) K060827 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
| Applicant | Esaote, S.p.A., Carmel IN, US |
| Decision | Substantially Equivalent, May 19, 2006 |
| Received | Mar 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060827
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.