K-number	K073147
Device name	SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
Applicant	Transoma Medical
Product code	MXC
Device class	Class II
Decision date	Dec 3, 2007
Decision	Substantially Equivalent
Regulation	870.2800

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View the full FDA submission: accessdata.fda.gov

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SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

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