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FDA 510(k)

Automatic Arm Electronic Blood Pressure Monitor

K-Number: K210435 · 2021-05-12

ApplicantShenzhen Lepu Intelligent Medical Equipment Co., Ltd.
Decision Date2021-05-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Arm Electronic Blood Pressure Monitor is a medical device manufactured by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-12 under approval number K210435. 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 Arm Electronic Blood Pressure Monitor?

Automatic Arm Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-05-12. It is manufactured by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K210435.

When was Automatic Arm Electronic Blood Pressure Monitor approved by the FDA?

Automatic Arm Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2021-05-12, under approval number K210435.

What company makes Automatic Arm Electronic Blood Pressure Monitor?

Automatic Arm Electronic Blood Pressure Monitor is manufactured by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd..

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

The FDA product code for Automatic Arm Electronic 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 Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K202776Fingertip pulse oximeter K202687Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

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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