510(k) K913323 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
ETUDE (MODEL NUMBERS 24A05 & 24A06)
| Applicant | Dantec Medical, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 23, 1991 |
| Received | Jul 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913323
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.