510(k) K991389 ยท FFX System, Gastrointestinal Motility (Electrical)
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
| Applicant | Medtronic Functional Diagnostics A/S, Copenhagen, DK |
| Decision | Substantially Equivalent, Jul 15, 1999 |
| Received | Apr 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991389
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.