Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor

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 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor.

Pre-market Notification Details

Device IDK212115
510k NumberK212115
Device Name:Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
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 Received2021-07-07
Decision Date2022-01-05

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