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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K100740
Device Name MD2000B VITAL SIGN MONITOR, MODEL MD2000B
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d Zhongxin Zhongshan
Mansion, # 19, Lane 999
Shanghai,  CN 20020
Applicant Contact DIANA HONG
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d Zhongxin Zhongshan
Mansion, # 19, Lane 999
Shanghai,  CN 20020
Correspondent Contact DIANA HONG
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/16/2010
Decision Date 07/09/2010
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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