K-number	K031320
Device name	EK-PRO ARRHYTHMIA DETECTION ALGORITHM
Applicant	Ge Medical Systems Information Technologies
Product code	MHX
Device class	Class II
Decision date	May 6, 2003
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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EK-PRO ARRHYTHMIA DETECTION ALGORITHM

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