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FDA 510(k)

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

K-Number: K241007 · 2024-10-24

ApplicantShenzhen Urion Technology Co., Ltd.
Decision Date2024-10-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) is a medical device manufactured by Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-24 under approval number K241007. 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 Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)?

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) is a medical device that received FDA 510(k) clearance on 2024-10-24. It is manufactured by Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K241007.

When was Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) approved by the FDA?

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) received FDA 510(k) clearance on 2024-10-24, under approval number K241007.

What company makes Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)?

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) is manufactured by Shenzhen Urion Technology Co., Ltd..

What is the FDA product code for Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)?

The FDA product code for Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) 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 Shenzhen Urion Technology Co., Ltd.

K160019U80 Series Upper Arm Electronic Blood Pressure Monitor K200802Infrared Thermometer K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

View all 7 devices →

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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