K-number	K082312
Device name	PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
Applicant	Heartscape Technologies, Ltd.
Product code	DPS
Device class	Class II
Decision date	Sep 12, 2008
Decision	Substantially Equivalent
Regulation	870.2340

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View the full FDA submission: accessdata.fda.gov

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PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)

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