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FDA 510(k)

Automatic Digital Blood Pressure Monitor

K-Number: K190982 · 2020-05-29

ApplicantXiamen Ants Bro Technology Co., Ltd.
Decision Date2020-05-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Digital Blood Pressure Monitor is a medical device manufactured by Xiamen Ants Bro Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under approval number K190982. 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 Automatic Digital Blood Pressure Monitor?

Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Xiamen Ants Bro Technology Co., Ltd.. The 510(k) number is K190982.

When was Automatic Digital Blood Pressure Monitor approved by the FDA?

Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2020-05-29, under approval number K190982.

What company makes Automatic Digital Blood Pressure Monitor?

Automatic Digital Blood Pressure Monitor is manufactured by Xiamen Ants Bro Technology Co., Ltd..

What is the FDA product code for Automatic Digital Blood Pressure Monitor?

The FDA product code for Automatic Digital 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) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Xiamen Ants Bro Technology Co., Ltd.

K190990Digital Thermometer K190984Infrared Forehead Thermometer

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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