510(k) K000386 ยท FFX System, Gastrointestinal Motility (Electrical)
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
| Applicant | Medtronic Functional Diagnostics A/S, Skovlunde, DK |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Feb 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000386
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.