Name: Predicase
Price: 199 USD

K-number	K092853
Device name	3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
Applicant	Galix Biomedical Instrumentation, Inc.
Product code	MLO
Device class	Class II
Decision date	Jul 9, 2010
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

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