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FDA 510(k)

Blood Pressure Monitor(Model:Y30001)

K-Number: K213023 · 2022-09-30

ApplicantZhangzhou Easepal Medical Science and Technology Co., Ltd.
Decision Date2022-09-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Blood Pressure Monitor(Model:Y30001) is a medical device manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-30 under approval number K213023. 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 Blood Pressure Monitor(Model:Y30001)?

Blood Pressure Monitor(Model:Y30001) is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd.. The 510(k) number is K213023.

When was Blood Pressure Monitor(Model:Y30001) approved by the FDA?

Blood Pressure Monitor(Model:Y30001) received FDA 510(k) clearance on 2022-09-30, under approval number K213023.

What company makes Blood Pressure Monitor(Model:Y30001)?

Blood Pressure Monitor(Model:Y30001) is manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd..

What is the FDA product code for Blood Pressure Monitor(Model:Y30001)?

The FDA product code for Blood Pressure Monitor(Model:Y30001) 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) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Zhangzhou Easepal Medical Science and Technology Co., Ltd.

K221800Infrared Thermometer (Model: Y20001, Y20002) K240373Air compression Leg Massager (MM0520, MM0521, MM0522)

Related Devices (Code: DXN)

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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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