510(k) K092997 ยท KNG Monitor, Ultrasonic, Fetal
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Nov 10, 2009 |
| Received | Sep 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092997
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.