K-number	K162012
Device name	CARESCAPE Central Station V2
Applicant	GE Healthcare
Product code	DXJ
Device class	Class II
Decision date	Sep 15, 2016
Decision	Substantially Equivalent
Regulation	870.2450

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Source

View the full FDA submission: accessdata.fda.gov

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CARESCAPE Central Station V2

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