510(k) K160287 ยท FFX System, Gastrointestinal Motility (Electrical)
Rapid Barostat Bag (RBB) Pump and Catheter
| Applicant | Mui Scientific, Mississauga, CA |
| Decision | Substantially Equivalent, Mar 14, 2017 |
| Received | Feb 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160287
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.