AGE Automatic Wrist Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Dongguan E-Test Technology Co., Ltd

The following data is part of a premarket notification filed by Dongguan E-test Technology Co., Ltd with the FDA for Age Automatic Wrist Blood Pressure Monitor.

Pre-market Notification Details

Device IDK193628
510k NumberK193628
Device Name:AGE Automatic Wrist Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Dongguan E-Test Technology Co., Ltd Room 201, 301. Building 1, Changping Section No.1, Dongshen Road Dongguan,  CN 523588
ContactVictor Wan
CorrespondentCassie Lee
DONGGUAN E-TEST TECHNOLOGY CO., LTD Room 201,301. Building 1, Changping Section No.1, Dongshen R Dongguan City,  CN 523588
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-07-12

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