K-number	K173226
Device name	CardiMax Electrocardiograph
Applicant	Fukuda Denshi USA, Inc.
Product code	DPS
Device class	Class II
Decision date	Apr 16, 2018
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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CardiMax Electrocardiograph

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