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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K904250
Device Name MODEL 4222 AMBULATORY ECG MONITOR
Applicant
Byrncrest Global, Inc.
P.O. Box 157
West Columbia,  TX  77486
Applicant Contact LISA JONES
Correspondent
Byrncrest Global, Inc.
P.O. Box 157
West Columbia,  TX  77486
Correspondent Contact LISA JONES
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/17/1990
Decision Date 02/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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