Name: Predicase
Price: 199 USD

K-number	K963811
Device name	CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
Applicant	Card Guard Scientific Survival , Ltd.
Product code	DXH
Device class	Class II
Decision date	Dec 4, 1996
Decision	Substantially Equivalent
Regulation	870.2920

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Source

View the full FDA submission: accessdata.fda.gov

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CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE

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