K-number	K973141
Device name	HEART ACCESS PLUS CARDIAC EVENT RECORDER
Applicant	Paceart, Inc.
Product code	DXH
Device class	Class II
Decision date	Nov 12, 1997
Decision	Substantially Equivalent
Regulation	870.2920

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View the full FDA submission: accessdata.fda.gov

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HEART ACCESS PLUS CARDIAC EVENT RECORDER

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