KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,

The following data is part of a premarket notification filed by Kodon(tianjin)electronic&electrical Apparatus Co., with the FDA for Kd-795 Wrist Measurement Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK070826
510k NumberK070826
Device Name:KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin,  CN 300193
ContactLiu Yi
CorrespondentLiu Yi
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin,  CN 300193
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-26
Decision Date2007-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00897037001038 K070826 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.