510(k) K971528 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
| Applicant | Fujinon, Inc., New York NY, US |
| Decision | Substantially Equivalent, Dec 12, 1997 |
| Received | Apr 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971528
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.