510(k) K944391 ยท FEN Device, Cystometric, Hydraulic
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
| Applicant | Surgitek, Racine WI, US |
| Decision | Substantially Equivalent, Feb 7, 1995 |
| Received | Sep 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944391
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.