510(k) K123565 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
PRESTO 1000 SYSTEM
| Applicant | Physiosonics, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Nov 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123565
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.