COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

Pump, Infusion

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Colleague (3cx, 3, Cx) Volumetric Infusion Pump.

Pre-market Notification Details

Device IDK003616
510k NumberK003616
Device Name:COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
ClassificationPump, Infusion
Applicant BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
ContactJennifer M Paine
CorrespondentJennifer M Paine
BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-22
Decision Date2000-12-12

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