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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 K992706
Device Name GALIX GBI -3S-LP
Applicant
Galix Biomedical Instrumentation, Inc.
2555 Collins Ave., C-5
Miami Beach,  FL  33140
Applicant Contact JORDAN GAVRIELIDES
Correspondent
Galix Biomedical Instrumentation, Inc.
2555 Collins Ave., C-5
Miami Beach,  FL  33140
Correspondent Contact JORDAN GAVRIELIDES
Regulation Number870.2800
Classification Product Code
MLO  
Date Received08/12/1999
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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