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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K022596
Device Name BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
Original Applicant
CLOVER HI-TECH INC.
17800 castleton st.
suite 415
city of industry,  CA  91748
Original Contact cecilia l yu
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/05/2002
Decision Date 01/31/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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