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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 K001244
Device Name BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
Applicant
Citizen Watch Co., Ltd.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact JOSEPH D EDMONDSON
Correspondent
Citizen Watch Co., Ltd.
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact JOSEPH D EDMONDSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/18/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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