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FDA 510(k)

YUWELL Electronic Blood Pressure Monitor

K-Number: K221372 · 2022-10-17

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2022-10-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

YUWELL Electronic Blood Pressure Monitor is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under approval number K221372. 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 YUWELL Electronic Blood Pressure Monitor?

YUWELL Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-10-17. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K221372.

When was YUWELL Electronic Blood Pressure Monitor approved by the FDA?

YUWELL Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2022-10-17, under approval number K221372.

What company makes YUWELL Electronic Blood Pressure Monitor?

YUWELL Electronic Blood Pressure Monitor is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL Electronic Blood Pressure Monitor?

The FDA product code for YUWELL Electronic 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 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D K201864YUWELL Infrared Thermometer K200939Electronic Blood Pressure Monitor K203583YUWELL infrared ear thermometer: YHT101, YHT200 K212385YUWELL Finger Pulse Oximeter K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

View all 12 devices →

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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