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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 K080933
Device Name HANDHELD ECG MONITOR, MODEL MD100
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d Zhongxin Zhongshan
Mansion, # 19, Ln. 999
Shanghai,  CN 20020
Applicant Contact Diana Hong
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d Zhongxin Zhongshan
Mansion, # 19, Ln. 999
Shanghai,  CN 20020
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/02/2008
Decision Date 09/26/2008
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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