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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 K890558
Device Name WELLSHIRE BASELINK
Applicant
American Executive Technology
9601 White Rock Trl. Suite
105
Dallas,  TX  75238
Applicant Contact JERRY ROBERTS
Correspondent
American Executive Technology
9601 White Rock Trl. Suite
105
Dallas,  TX  75238
Correspondent Contact JERRY ROBERTS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/06/1989
Decision Date 03/09/1989
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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