510(k) K061325 ยท FRN Pump, Infusion
BODYGAURD PAIN MANAGER INFUSION SYSTEM
| Applicant | Caesarea Medical Electronics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | May 11, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2020 | CME America, LLC CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.