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FDA 510(k)

Upper Arm Blood Pressure Monitor

K-Number: K191673 · 2019-11-27

ApplicantFamidoc Technology Company Limited
Decision Date2019-11-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Blood Pressure Monitor is a medical device manufactured by Famidoc Technology Company Limited. It received FDA 510(k) clearance on 2019-11-27 under approval number K191673. 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 Blood Pressure Monitor?

Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Famidoc Technology Company Limited. The 510(k) number is K191673.

When was Upper Arm Blood Pressure Monitor approved by the FDA?

Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2019-11-27, under approval number K191673.

What company makes Upper Arm Blood Pressure Monitor?

Upper Arm Blood Pressure Monitor is manufactured by Famidoc Technology Company Limited.

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

The FDA product code for Upper 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 Famidoc Technology Company Limited

K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor K233192Wireless Smart Thermometer

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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