Name: Predicase
Price: 199 USD

K-number	K103678
Device name	CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
Applicant	Ge Medical Systems Information Technologies GmbH
Product code	DQK
Device class	Class II
Decision date	Feb 16, 2011
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

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