Name: Predicase
Price: 199 USD

K-number	K063696
Device name	COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
Applicant	Baxterhealthcare, Inc.
Product code	FRN
Device class	Class II
Decision date	Feb 27, 2007
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163

Everything you need for a 510(k) submission. Nothing you don't.