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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 K112690
Model WSK-1011
Device Name BLOOD PRESSURE MONITOR
Applicant
NIHON SEIMITSU SOKKI CO., LTD.
6-5-3 beaune honkomagome 2f
honkomagome
bunkyo-ku, tokyo, 
Contact koji kubo
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/15/2011
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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