The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Colleague Guardian Configuration Tool; Colleague Dl2 Event History Download Software Application.
| Device ID | K070125 |
| 510k Number | K070125 |
| Device Name: | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION |
| Classification | Pump, Infusion |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Jeme Wallace |
| Correspondent | Jeme Wallace BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-04-16 |
| Summary: | summary |