510(k) K101091 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Z.ONE ULTRA ULTRASOUND SYSTEM
| Applicant | Zonare Medical Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Apr 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101091
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.