510(k) K153421 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
| Applicant | Hitachi Aloka Medical America, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Nov 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153421
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.