510(k) K041241 ยท FRN Pump, Infusion
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 6, 2004 |
| Received | May 11, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Open, Classified |
FRN | None listed |
| Dec 20, 2013 | CareFusion 303, Inc. Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600.
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.