Fully Automatic Electronic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Andon Health Co., Ltd.

The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Fully Automatic Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK183535
510k NumberK183535
Device Name:Fully Automatic Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin,  CN 300190
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-19
Decision Date2019-06-04

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