Name: Predicase
Price: 199 USD

K-number	K091206
Device name	SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
Applicant	Transoma Medical
Product code	MXC
Device class	Class II
Decision date	May 18, 2009
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL

Everything you need for a 510(k) submission. Nothing you don't.