Name: Predicase
Price: 199 USD

K-number	K972242
Device name	REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
Applicant	Medtronic Vascular
Product code	MXC
Device class	Class II
Decision date	Jan 16, 1998
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

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