510(k) K963064 ยท FFX System, Gastrointestinal Motility (Electrical)
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
| Applicant | Laborie Medical Tech Corp., Williston VT, US |
| Decision | Substantially Equivalent, Jun 5, 1997 |
| Received | Aug 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963064
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.