K961703 is an FDA 510(k) clearance for the COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL). 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 July 8, 1996, 67 days after receiving the submission on May 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K961703 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1996 |
| Decision Date | July 08, 1996 |
| Days to Decision | 67 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 |