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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 K923344
Device Name ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
Applicant
Citizen Watch Co., Ltd.
1880 Century Park E.
Suite 519
Los Angeles,  CA  90067
Applicant Contact WILLIAM ANDROLIA
Correspondent
Citizen Watch Co., Ltd.
1880 Century Park E.
Suite 519
Los Angeles,  CA  90067
Correspondent Contact WILLIAM ANDROLIA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/18/1992
Decision Date 10/07/1993
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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