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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 K151281
Device Name AGE Automatic Wrist Blood Pressure Monitor
Applicant
Dongguan Ageless Health Industrial Co., Ltd.
3/F, A1 Bldg
Dongshen Sima Industrial Area, #33 Shenbei Rd.
Dongguan,  CN 523560
Applicant Contact VICTOR WAN
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd.,
Guahgzhou Science Park
Guangzhou,  CN 510663
Correspondent Contact CECILIA CENG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/14/2015
Decision Date 06/30/2015
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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