510(k) K921047 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
MODEL 8100 URODYNAMICS MEASURING SYSTEM
| Applicant | Browne Medical Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 10, 1992 |
| Received | Feb 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921047
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.