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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 K963904
Device Name P.H.D. - PERSONAL HEART DEVICE MODEL 5258
Applicant
Heart Alert, Inc.
6140 Central Church Rd.
Douglasville,  GA  30135
Applicant Contact CATHY FAUST
Correspondent
Heart Alert, Inc.
6140 Central Church Rd.
Douglasville,  GA  30135
Correspondent Contact CATHY FAUST
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/30/1996
Decision Date 05/15/1997
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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