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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K011328
Device Name CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
Applicant
Bionet Company, Ltd.
3f, Daeyang Bldg., 999
Daechi-Dong, Kangnam-Gu
Seoul,  KR
Applicant Contact MIN SOO HAN
Correspondent
Bionet Company, Ltd.
3f, Daeyang Bldg., 999
Daechi-Dong, Kangnam-Gu
Seoul,  KR
Correspondent Contact MIN SOO HAN
Classification Product Code
LOS
Date Received05/01/2001
Decision Date 11/21/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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