K-number	K042177
Device name	MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Applicant	Ge Medical Systems Information Technologies
Product code	DPS
Device class	Class II
Decision date	Aug 27, 2004
Decision	Substantially Equivalent
Regulation	870.2340

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

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