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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K093013
Device Name BLOOD PRESSURE MONITOR, MODEL MD200A
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 5d, # 19, Ln. 999
Zhongshan # 2 Rd.(S)
Shanghai,  CN 20030
Applicant Contact LEE FU
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 5d, # 19, Ln. 999
Zhongshan # 2 Rd.(S)
Shanghai,  CN 20030
Correspondent Contact LEE FU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/29/2009
Decision Date 01/08/2010
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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