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FDA 510(k)

Arm Blood Pressure Monitor

K-Number: K192023 · 2019-12-23

ApplicantTruly Instrument Limited
Decision Date2019-12-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Blood Pressure Monitor is a medical device manufactured by Truly Instrument Limited. It received FDA 510(k) clearance on 2019-12-23 under approval number K192023. 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 Arm Blood Pressure Monitor?

Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Truly Instrument Limited. The 510(k) number is K192023.

When was Arm Blood Pressure Monitor approved by the FDA?

Arm Blood Pressure Monitor received FDA 510(k) clearance on 2019-12-23, under approval number K192023.

What company makes Arm Blood Pressure Monitor?

Arm Blood Pressure Monitor is manufactured by Truly Instrument Limited.

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

The FDA product code for Arm 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 Truly Instrument Limited

K161846Automatic Arm Bluetooth Blood Pressure Monitor K220276Infrared Thermometer TET-351

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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