K-number	K181998
Device name	CardioBand ECG Event Recorder
Applicant	Samsung Strategy and Innovation Center (Ssic)
Product code	DPS
Device class	Class II
Decision date	Nov 15, 2018
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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CardioBand ECG Event Recorder

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