510(k) K862295 ยท FRN Pump, Infusion
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
| Applicant | Imed Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 23, 1986 |
| Received | Jun 17, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2007 | Cardinal Health 303 Inc DBA Alaris Products All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syring Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.