510(k) K092853

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM by Galix Biomedical Instrumentation, Inc. — Product Code MLO

K092853 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM". The FDA issued a decision of Substantially Equivalent on July 9, 2010. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.