Name: Predicase
Price: 199 USD

K-number	K120550
Device name	CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	May 7, 2012
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

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