Upper Arm Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

ShenZhen ZhengKang Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Zhengkang Technology Co., Ltd. with the FDA for Upper Arm Blood Pressure Monitor.

Pre-market Notification Details

Device IDK191894
510k NumberK191894
Device Name:Upper Arm Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ShenZhen ZhengKang Technology Co., Ltd. 3/F, Building A, No. 3 FuXing Yi Lane, HeHua Community, PingHu Street Shenzhen City,  CN 518100
ContactHuayong Yang
CorrespondentBecky Chen
Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No 22 Guimiao Rd. Shenzhen City,  CN 518100
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-15
Decision Date2020-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06922119300151 K191894 000
06922119301363 K191894 000
06922119301370 K191894 000
06922119301387 K191894 000
10850632007260 K191894 000
06922119300915 K191894 000
06922119300120 K191894 000
06922119300137 K191894 000
06922119300144 K191894 000
06922119301356 K191894 000

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