510(k) K851895 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
POLYGEL ULTRASOUND GEL
| Applicant | Parker Laboratories, Inc., Orange NJ, US |
| Decision | Substantially Equivalent, Sep 27, 1985 |
| Received | Apr 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851895
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.