510(k) K012232 ยท FFX System, Gastrointestinal Motility (Electrical)
INSIGHT, MODEL S980000
| Applicant | Sandhill Scientific, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jun 7, 2002 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2023 | Diversatek Healthcare ZVU Functional GI Software, REF: ZVU-3 Open, Classified |
FFX | None listed |
| May 7, 2012 | Sandhill Scientific, Inc Insight rev H software.
The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal stud Terminated |
FFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.