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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 K090936
Device Name SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
Applicant
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Lane 999
Zhong Shan, Shanghai,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/02/2009
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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