510(k) K891386 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CVIS ULTRA-SCAN ONE IMAGING SYSTEM
| Applicant | Cardiovascular Imaging Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 16, 1989 |
| Received | Mar 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891386
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.