Name: Predicase
Price: 199 USD

K-number	K122090
Device name	SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
Applicant	St. Jude Medical, Cardiac Rhythm Management Divisi
Product code	MXC
Device class	Class II
Decision date	Nov 15, 2012
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 IMPLANTABLE CARDIAC MONITOR

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