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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 K952494
Device Name DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
Applicant
Nihon Seimitsu Sokki Co., Ltd.
1125-7 Sekishita
Shibukawa-Shi, Gunma-Ken,  JP 377-0293
Applicant Contact S. KOSHINO
Correspondent
Nihon Seimitsu Sokki Co., Ltd.
1125-7 Sekishita
Shibukawa-Shi, Gunma-Ken,  JP 377-0293
Correspondent Contact S. KOSHINO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/30/1995
Decision Date 12/28/1995
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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