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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
Device Name COMPACT DIGITAL BLOOD PRESSURE MONITOR
Applicant
Thermor , Ltd.
16975 Leslie St.
Newmarket,  CA L3Y 9A1
Applicant Contact MARK BEATON
Correspondent
Thermor , Ltd.
16975 Leslie St.
Newmarket,  CA L3Y 9A1
Correspondent Contact MARK BEATON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/13/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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