510(k) K853936 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
1351 UROFLOW AUTO START
| Applicant | Life-Tech Intl., Inc., Houston TX, US |
| Decision | Substantially Equivalent, Dec 2, 1985 |
| Received | Sep 24, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853936
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.