510(k) K050552 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
PACHPEN PACHYMETER, MODEL 24-5100
| Applicant | Accutome, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 28, 2005 |
| Received | Mar 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050552
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.