Name: Predicase
Price: 199 USD

K-number	K113811
Device name	V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
Applicant	C.R. Bard Inc., Bard Electrophysiology Division
Product code	DQK
Device class	Class II
Decision date	Mar 16, 2012
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

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