The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Colleague Cx Volumetric Infusion Pump 2m8161 And Volumeteric Infusion Pump 2m8151.
| Device ID | K002211 |
| 510k Number | K002211 |
| Device Name: | COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Jennifer M Paine |
| Correspondent | Jennifer M Paine BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-21 |
| Decision Date | 2000-07-28 |