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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 K123882
Device Name AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
Applicant
Ageless Health Industrial
3f, A1 Bldg, Dongshen Sima Industrial Area
# 33 Shenbei Rd., Changping
Dongguan, Guangdong,  CN 523570
Applicant Contact VICTOR WAN
Correspondent
Ageless Health Industrial
3f, A1 Bldg, Dongshen Sima Industrial Area
# 33 Shenbei Rd., Changping
Dongguan, Guangdong,  CN 523570
Correspondent Contact VICTOR WAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/17/2012
Decision Date 08/14/2013
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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