510(k) K941984 ยท FRN Pump, Infusion
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
| Applicant | Sabratek Corp., Chicago IL, US |
| Decision | Substantially Equivalent, Jul 19, 1994 |
| Received | Apr 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941984
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2005 | Baxter Healthcare Corp. Epidural Infusion Pumps sold under the following labels;
a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deer Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.