510(k) K875128 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
TRANS/R NEEDLE GUIDE
| Applicant | CIVCO Medical Instruments Co., Inc., Kalona IA, US |
| Decision | Substantially Equivalent, Apr 15, 1988 |
| Received | Dec 15, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875128
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.