510(k) K070943 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
B-SCAN PLUS
| Applicant | Accutome Ultrasound, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 19, 2007 |
| Received | Apr 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070943
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.