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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 K052046
Device Name BLOOD PRESSURE METER, MODEL CH-432
Applicant
Citizen Watch Co., Ltd.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact JOSEPH EDMONDSON
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/29/2005
Decision Date 10/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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