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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 K050697
Device Name MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
Applicant
Nihon Seimitsu Sokki Co., Ltd.
203 Main St., 166
Flemington,  NJ  08822
Applicant Contact LYNETTE HOWARD
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/18/2005
Decision Date 03/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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