510(k) K013154 ยท FFX System, Gastrointestinal Motility (Electrical)
MARK II/MARK III MANOMETRIC PERFUSION PUMP
| Applicant | Dentsleeve Pty., Ltd., Golden CO, US |
| Decision | Substantially Equivalent, Oct 19, 2001 |
| Received | Sep 20, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013154
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.