510(k) K912451 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
URODYNAMIC RECTAL BALLOON
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Dec 2, 1991 |
| Received | Jun 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912451
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.