510(k) K001386 ยท FEN Device, Cystometric, Hydraulic
ACCUSET SENSOR, MODEL 2000
| Applicant | Pelvicare, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Jul 17, 2000 |
| Received | May 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001386
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.