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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
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