510(k) K121014 ยท FFX System, Gastrointestinal Motility (Electrical)
SOLAR GI
| Applicant | Medical Measurement Systems B.V., Enschede Overijssel, NL |
| Decision | Substantially Equivalent, Aug 1, 2012 |
| Received | Apr 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Laborie Medical Technologies Corp Solar GI System (Water Perfusion);
Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley syste Open, Classified |
FFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.