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FDA 510(k)

Wrist Blood Pressure Monitor

K-Number: K232815 · 2023-12-11

ApplicantZhuhai Yueja Medical Device Technology Co., Ltd.
Decision Date2023-12-11
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Blood Pressure Monitor is a medical device manufactured by Zhuhai Yueja Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under approval number K232815. 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 Blood Pressure Monitor?

Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Zhuhai Yueja Medical Device Technology Co., Ltd.. The 510(k) number is K232815.

When was Wrist Blood Pressure Monitor approved by the FDA?

Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2023-12-11, under approval number K232815.

What company makes Wrist Blood Pressure Monitor?

Wrist Blood Pressure Monitor is manufactured by Zhuhai Yueja Medical Device Technology Co., Ltd..

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

The FDA product code for Wrist 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 Zhuhai Yueja Medical Device Technology Co., Ltd.

K232814Electronic Blood Pressure Monitor K232473Infrared Thermometer: Model YJ600

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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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