The following data is part of a premarket notification filed by Baxterhealthcare, Inc. with the FDA for Colleague Volumetric Infusion Pump Model# 2m8151,8153,8161,8163,9161,9163.
| Device ID | K063696 |
| 510k Number | K063696 |
| Device Name: | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 |
| Classification | Pump, Infusion |
| Applicant | BAXTERHEALTHCARE, INC. ONE BAXTER PARKWAY Deerfield, IL 60015 -4633 |
| Contact | Jeme Wallace |
| Correspondent | Jeme Wallace BAXTERHEALTHCARE, INC. ONE BAXTER PARKWAY Deerfield, IL 60015 -4633 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-02-27 |
| Summary: | summary |