Upper Arm Electronic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Conmo Electronic Company Limited

The following data is part of a premarket notification filed by Conmo Electronic Company Limited with the FDA for Upper Arm Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK202372
510k NumberK202372
Device Name:Upper Arm Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Conmo Electronic Company Limited Room 1402, Building No.10,Shenzhen Biomedicine Innovations Industrial Park, Jinhui Road No.14,Kengzi Street, Pingshan D Shenzhen City,  CN 518126
ContactAlice Qi
CorrespondentCharlie Mack
International Regulatory Consultants 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2020-12-30

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