Name: Predicase
Price: 199 USD

K-number	K081365
Device name	SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
Applicant	St Jude Medical
Product code	MXC
Device class	Class II
Decision date	Aug 15, 2008
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR

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