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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K092853
Device Name 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
Applicant
GALIX BIOMEDICAL INSTRUMENTATION, INC.
2555 COLLINS AVE., C-5
MIAMI BEACH,  FL  33140
Applicant Contact YOEL PALOMINO
Correspondent
GALIX BIOMEDICAL INSTRUMENTATION, INC.
2555 COLLINS AVE., C-5
MIAMI BEACH,  FL  33140
Correspondent Contact YOEL PALOMINO
Regulation Number870.2800
Classification Product Code
MLO  
Date Received09/16/2009
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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