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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 K061161
Device Name BLOOD PRESSURE METER, MODEL CH-311B
Applicant
Citizen Watch Co., Ltd.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact JOSEPH D EDMONDSON JR.
Correspondent
Citizen Watch Co., Ltd.
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact JOSEPH D EDMONDSON JR.
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/26/2006
Decision Date 06/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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