Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Yuezhongxing Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Yuezhongxing Technology Co., Ltd. with the FDA for Wrist Blood Pressure Monitor, Model Name:w203, Wrist Blood Pressure Monitor, Model Name:w202, Wrist Blood Pressure Monitor, Model Name:w1681.

Pre-market Notification Details

Device IDK211041
510k NumberK211041
Device Name:Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Yuezhongxing Technology Co., Ltd. No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen,  CN 518015
ContactYuchao Chen
CorrespondentYuchao Chen
Shenzhen Yuezhongxing Technology Co., Ltd. No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen,  CN 518015
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-08
Decision Date2021-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971209160038 K211041 000
06971209160151 K211041 000
06971209160168 K211041 000
06971209160175 K211041 000
06971209160182 K211041 000
06971209162018 K211041 000
06971209162032 K211041 000
06971209160045 K211041 000
06971209160052 K211041 000
06971209160069 K211041 000
06971209160014 K211041 000
06971209160021 K211041 000
06971209162025 K211041 000

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