K022203 is an FDA 510(k) clearance for the ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 1, 2002, 27 days after receiving the submission on July 5, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K022203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2002 |
| Decision Date | August 01, 2002 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |