510(k) K904646 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
BCI-100 FECAL INCONTINENCE SYSTEM
| Applicant | Biocare Intl., Wantagh NY, US |
| Decision | Substantially Equivalent, Mar 19, 1991 |
| Received | Oct 11, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904646
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.