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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 K122810
Model BD204
Device Name COMPACT DIGITAL BLOOD PRESSURE MONITOR
Applicant
THERMOR LTD.
16975 leslie st.
newmarket, 
Contact mark beaton
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/13/2012
Decision Date 02/08/2013
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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