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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 K193628
Device Name AGE Automatic Wrist Blood Pressure Monitor
Applicant
Dongguan E-Test Technology Co., Ltd.
Rm. 201, 301. Bldg. 1, Changping Section #1,
Dongshen Rd.
Dongguan,  CN 523588
Applicant Contact Victor Wan
Correspondent
Dongguan E-Test Technology Co., Ltd.
Rm. 201,301. Bldg. 1, Changping Section #1, Dongshen R
Dongguan City,  CN 523588
Correspondent Contact Cassie Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/26/2019
Decision Date 07/12/2020
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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