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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K971670
Device Name 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
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
DSH  
Date Received05/06/1997
Decision Date 01/29/1998
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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