Name: Predicase
Price: 199 USD

K-number	K043380
Device name	MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Applicant	Monebo Technologies, Inc.
Product code	DPS
Device class	Class II
Decision date	Apr 26, 2005
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1

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