Name: Predicase
Price: 199 USD

K-number	K071995
Device name	CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Applicant	Card Guard Scientific Survival , Ltd.
Product code	DSI
Device class	Class II
Decision date	Dec 18, 2007
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR

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