510(k) K904359 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ESI-3000 ULTRASOUND SYSTEM
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Mar 5, 1991 |
| Received | Sep 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904359
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.