510(k) K990441 ยท FFX System, Gastrointestinal Motility (Electrical)
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
| Applicant | Sandhill Scientific, Inc., Highlands Ranch CO, US |
| Decision | Substantially Equivalent, May 12, 1999 |
| Received | Feb 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990441
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.