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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 K193627
Device Name Automatic Upper Arm Blood Pressure Monitor
Applicant
Dongguan E-Test Technology Co., LTD
Room 201,301. Building 1, Changping Section No.1
Dongshen Road
Dongguan,  CN 523588
Applicant Contact Victor Wan
Correspondent
DONGGUAN E-TEST TECHNOLOGY CO., LTD
Room 201,301. Building 1, Changping Section No.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
Recalls CDRH Recalls
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