510(k) K010130 ยท FFX System, Gastrointestinal Motility (Electrical)
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
| Applicant | Medtronic Functional Diagnostics A/S, Skovlunde, DK |
| Decision | Substantially Equivalent, Feb 7, 2001 |
| Received | Jan 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010130
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.