K031566 is an FDA 510(k) clearance for the SYNDEO PCA SYRINGE PUMP, MODEL 2L3113. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on August 19, 2003, 92 days after receiving the submission on May 19, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K031566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2003 |
| Decision Date | August 19, 2003 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| 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 |