K-number	K163530
Device name	PrisMax Control Unit
Applicant	Baxter Healthcare Corp
Product code	KDI
Device class	Class II
Decision date	May 3, 2017
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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PrisMax Control Unit

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