510(k) K031749 ยท FRN Pump, Infusion
BODYGUARD INFUSION SYSTEM
| Applicant | Caesarea Medical Electronics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Aug 21, 2003 |
| Received | Jun 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2020 | CME America, LLC BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA the Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.