K-number	K032736
Device name	HEART 2006
Applicant	Aerotel Medical Systems (1998) , Ltd.
Product code	DXH
Device class	Class II
Decision date	Oct 3, 2003
Decision	Substantially Equivalent
Regulation	870.2920

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Source

View the full FDA submission: accessdata.fda.gov

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HEART 2006

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