510(k) K970595 ยท FEN Device, Cystometric, Hydraulic
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
| Applicant | Circon Video, Santa Barbara CA, US |
| Decision | Substantially Equivalent, Oct 24, 1997 |
| Received | Feb 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970595
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.