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FDA 510(k)

Upper Arm Blood Pressure Monitor

K-Number: K230176 · 2023-06-29

ApplicantShenzhen Yolanda Technology Co., Ltd.
Decision Date2023-06-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Blood Pressure Monitor is a medical device manufactured by Shenzhen Yolanda Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-29 under approval number K230176. 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 Upper Arm Blood Pressure Monitor?

Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by Shenzhen Yolanda Technology Co., Ltd.. The 510(k) number is K230176.

When was Upper Arm Blood Pressure Monitor approved by the FDA?

Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2023-06-29, under approval number K230176.

What company makes Upper Arm Blood Pressure Monitor?

Upper Arm Blood Pressure Monitor is manufactured by Shenzhen Yolanda Technology Co., Ltd..

What is the FDA product code for Upper Arm Blood Pressure Monitor?

The FDA product code for Upper Arm Blood Pressure Monitor is DXN.

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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 Shenzhen Yolanda Technology Co., Ltd.

K221211Infrared thermometer K221212Upper Arm Blood Pressure Monitor

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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