510(k) K913113 ยท FEN Device, Cystometric, Hydraulic
FST CATH-UD CATHETER, MODIFICATION
| Applicant | Fiberoptic Sensor Technlogies, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Oct 9, 1991 |
| Received | Jul 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913113
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.