K-number	K170506
Device name	ECG Check - Universal, ECG Check - Universal Plus
Applicant	Cardiac Designs, Inc.
Product code	DXH
Device class	Class II
Decision date	Oct 2, 2017
Decision	Substantially Equivalent
Regulation	870.2920

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Source

View the full FDA submission: accessdata.fda.gov

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ECG Check - Universal, ECG Check - Universal Plus

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