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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 K122482
Models TMB-1014, TMB-1117, TMB-895, TMB-988
Device Name TRANSTEK WRIST BLOOD PRESSURE MONITOR
Applicant
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
no. 1 fanghua street
hi-tech zone
chengdu, 
Contact leo wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/14/2012
Decision Date 10/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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