K010566 is an FDA 510(k) clearance for the COLLEAGUE VOLUMETRIC INFUSION PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 15, 2001, 78 days after receiving the submission on February 26, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K010566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2001 |
| Decision Date | May 15, 2001 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| 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 |