510(k) K011472 ยท FFX System, Gastrointestinal Motility (Electrical)
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
| Applicant | Medtronic Functional Diagnostics A/S, Skovlunde, DK |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | May 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011472
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.