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FDA 510(k)

Digital Blood Pressure Monitor (Arm Type)

K-Number: K231245 · 2023-11-22

ApplicantGuangdong Genial Technology Co., Ltd.
Decision Date2023-11-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor (Arm Type) is a medical device manufactured by Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-22 under approval number K231245. 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 Digital Blood Pressure Monitor (Arm Type)?

Digital Blood Pressure Monitor (Arm Type) is a medical device that received FDA 510(k) clearance on 2023-11-22. It is manufactured by Guangdong Genial Technology Co., Ltd.. The 510(k) number is K231245.

When was Digital Blood Pressure Monitor (Arm Type) approved by the FDA?

Digital Blood Pressure Monitor (Arm Type) received FDA 510(k) clearance on 2023-11-22, under approval number K231245.

What company makes Digital Blood Pressure Monitor (Arm Type)?

Digital Blood Pressure Monitor (Arm Type) is manufactured by Guangdong Genial Technology Co., Ltd..

What is the FDA product code for Digital Blood Pressure Monitor (Arm Type)?

The FDA product code for Digital Blood Pressure Monitor (Arm Type) 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 Guangdong Genial Technology Co., Ltd.

K231250Digital Blood Pressure Monitor K231243Finger Clip Pulse Oximeter K240333Wearable Digital Thermometer (T31) K232678Digital Thermometer, Model T28, T28L

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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