YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500

System, Measurement, Blood-pressure, Non-invasive

YA HORNG ELECTRONIC CO., LTD.

The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-100j, Bp-110j; Digital Wrist Blood Pressure Monitor, Bp-500,bp-500.

Pre-market Notification Details

Device IDK072860
510k NumberK072860
Device Name:YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
ContactKe-min Jen
CorrespondentKe-min Jen
YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-05
Decision Date2008-02-25
Summary:summary

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