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FDA 510(k)

Wrist Type Blood Pressure Monitor

K-Number: K162616 · 2018-03-09

ApplicantXuzhou Yongkang Electronic Science Technology Co., Ltd.
Decision Date2018-03-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Type Blood Pressure Monitor is a medical device manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-09 under approval number K162616. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist Type Blood Pressure Monitor?

Wrist Type Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K162616.

When was Wrist Type Blood Pressure Monitor approved by the FDA?

Wrist Type Blood Pressure Monitor received FDA 510(k) clearance on 2018-03-09, under approval number K162616.

What company makes Wrist Type Blood Pressure Monitor?

Wrist Type Blood Pressure Monitor is manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd..

What is the FDA product code for Wrist Type Blood Pressure Monitor?

The FDA product code for Wrist Type Blood Pressure Monitor is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Xuzhou Yongkang Electronic Science Technology Co., Ltd.

K161938Fingertip Pulse Oximeter K180314Infrared Thermometer K183491Arm Blood Pressure Monitor K191571UV Radiation Treatment System K252709Wireless Probe Type Ultrasound Scanner

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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