510(k) K963315 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
| Applicant | Vingmed Sound, Inc., Williamsburg VA, US |
| Decision | Substantially Equivalent, Mar 17, 1997 |
| Received | Aug 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963315
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.