510(k) K080087 ยท KNG Monitor, Ultrasonic, Fetal
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Mar 11, 2008 |
| Received | Jan 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080087
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.