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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 K003444
Device Name MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
Applicant
Nihon Seimitsu Sokki Co., Ltd.
222 Institute St.
Smithfield,  VA  23430
Applicant Contact ROBERT D WAXHAM
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/06/2000
Decision Date 11/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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