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FDA 510(k)

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

K-Number: K181104 · 2018-08-29

ApplicantShenzhen Combei Technology Co., Ltd.
Decision Date2018-08-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device manufactured by Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under approval number K181104. 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 type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K181104.

When was Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style approved by the FDA?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style received FDA 510(k) clearance on 2018-08-29, under approval number K181104.

What company makes Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style is manufactured by Shenzhen Combei Technology Co., Ltd..

What is the FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

The FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style 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 Combei Technology Co., Ltd.

K163606Digital Blood Pressure Monitor-Automatic Upper Arm Style K171833Digital Blood Pressure Monitor-Wrist Style K202741Infrared Forehead 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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