510(k) K963290 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
| Applicant | Endosonics Corp., Rancho Cordova CA, US |
| Decision | Substantially Equivalent, Aug 6, 1997 |
| Received | Aug 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963290
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.