K002739 is an FDA 510(k) clearance for the INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 11, 2000, 10 days after receiving the submission on September 1, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K002739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2000 |
| Decision Date | September 11, 2000 |
| Days to Decision | 10 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 |