Automatic Arm Electronic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. with the FDA for Automatic Arm Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK210435
510k NumberK210435
Device Name:Automatic Arm Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North Side Of Floor 3, BLD 9 BaiWangxin High-Tech Industrial Park, Songbai Road Shenzhen,  CN 518055
ContactAaron Lin
CorrespondentArthur Goddard
FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights,  OH  44124 -4445
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-12
Decision Date2021-05-12

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