510(k) K032147 ยท FRN Pump, Infusion
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 25, 2003 |
| Received | Jul 14, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2006 | Cardinal Health 303 Inc DBA Alaris Products Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.