Name: Predicase
Price: 199 USD

K-number	K151269
Device name	ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
Applicant	Lifewatch Technologies , Ltd.
Product code	DSI
Device class	Class II
Decision date	Jan 15, 2016
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

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