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FDA 510(k)

Electronic Blood Pressure Monitor

K-Number: K243661 · 2025-02-07

ApplicantHetaida Technology Co., Ltd.
Decision Date2025-02-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Blood Pressure Monitor is a medical device manufactured by Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-07 under approval number K243661. 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 Electronic Blood Pressure Monitor?

Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2025-02-07. It is manufactured by Hetaida Technology Co., Ltd.. The 510(k) number is K243661.

When was Electronic Blood Pressure Monitor approved by the FDA?

Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2025-02-07, under approval number K243661.

What company makes Electronic Blood Pressure Monitor?

Electronic Blood Pressure Monitor is manufactured by Hetaida Technology Co., Ltd..

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

The FDA product code for 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 Hetaida Technology Co., Ltd.

K171888Non-contact infrared body thermometer K180385Infrared Body Thermometer K180387Infrared Ear Thermometer K203332Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C K200159Non-contact Infrared Body Thermometer, model:HTD8823US K223170Electronic Blood Pressure Monitor, model: HTD6602US

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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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