COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION

Pump, Infusion

BAXTER HEALTHCARE CORP.

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.

Pre-market Notification Details

Device IDK070125
510k NumberK070125
Device Name:COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
ClassificationPump, Infusion
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactJeme Wallace
CorrespondentJeme Wallace
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-16
Decision Date2007-04-16
Summary:summary

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