510(k) K961229 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HR12000 ULTRASOUND SYSTEM
| Applicant | International Ultrasound Corp., Englewood NJ, US |
| Decision | Substantially Equivalent, May 29, 1997 |
| Received | Mar 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961229
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.