K024084 is an FDA 510(k) clearance for the ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 31, 2002, 20 days after receiving the submission on December 11, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K024084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2002 |
| Decision Date | December 31, 2002 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |