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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 K100553
Device Name BLOOD PRESSURE METER MODEL CH-101
Applicant
Citizen Systems Japan Co., Ltd.
3000 K St. NW
Suite 600
Washington,  DC  20007
Applicant Contact NATHAN A BEAVER
Correspondent
Citizen Systems Japan Co., Ltd.
3000 K St. NW
Suite 600
Washington,  DC  20007
Correspondent Contact NATHAN A BEAVER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/26/2010
Decision Date 05/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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