510(k) K082701 ยท FEN Device, Cystometric, Hydraulic
URONIRS, MODEL 2000
| Applicant | Urodynamix Technologies, Ltd., Vancouver Bc, CA |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Sep 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082701
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.