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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K851322
Device Name PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
Applicant
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Applicant Contact JULIAN P KAYE
Correspondent
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Correspondent Contact JULIAN P KAYE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/02/1985
Decision Date 05/16/1985
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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