510(k) K042122 ยท MEB Pump, Infusion, Elastomeric
SMARTINFUSER PAINPUMP
| Applicant | Precise Medical Products, Shlomi, IL |
| Decision | Substantially Equivalent, Sep 22, 2004 |
| Received | Aug 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2011 | Hsmg, Inc. D/b/a Smartinfuser Usa SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD. Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.