510(k) K980946 ยท FFX System, Gastrointestinal Motility (Electrical)
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
| Applicant | Dentsleeve Pty., Ltd., Parkside South Australia, AU |
| Decision | Substantially Equivalent, Jun 8, 1998 |
| Received | Mar 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980946
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.