Name: Predicase
Price: 199 USD

K-number	K013717
Device name	BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
Applicant	Brentwood Medical Technology Corp.
Product code	DPS
Device class	Class II
Decision date	Feb 6, 2002
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

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