The Wrist-Type Fully Automatic Digital Blood Pressure Monitors

System, Measurement, Blood-pressure, Non-invasive

Joytech Healthcare Co., Ltd.

The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for The Wrist-type Fully Automatic Digital Blood Pressure Monitors.

Pre-market Notification Details

Device IDK170666
510k NumberK170666
Device Name:The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
ContactRen Yunhua
CorrespondentRen Yunhua
Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-06
Decision Date2017-11-22
Summary:summary

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