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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K863965
Device Name KENZ-ECG 102
Applicant
Compumed, Inc.
8549 Higuera St.
Culver City,  CA  90230
Applicant Contact MCSHARRY
Correspondent
Compumed, Inc.
8549 Higuera St.
Culver City,  CA  90230
Correspondent Contact MCSHARRY
Regulation Number870.2330
Classification Product Code
DXK  
Date Received10/10/1986
Decision Date 12/22/1986
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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