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 IDK163276
510k NumberK163276
Device Name:Fully Automatic Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ANDON HEALTH CO.,LTD NO 3, JIN PING ST, YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO.,LTD NO 3, JIN PING ST, YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-21
Decision Date2017-05-11
Summary:summary

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