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FDA 510(k)

Digital Blood Pressure Monitor-Wrist Style

K-Number: K171833 · 2018-01-10

ApplicantShenzhen Combei Technology Co., Ltd.
Decision Date2018-01-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor-Wrist Style is a medical device manufactured by Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-10 under approval number K171833. 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 Digital Blood Pressure Monitor-Wrist Style?

Digital Blood Pressure Monitor-Wrist Style is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K171833.

When was Digital Blood Pressure Monitor-Wrist Style approved by the FDA?

Digital Blood Pressure Monitor-Wrist Style received FDA 510(k) clearance on 2018-01-10, under approval number K171833.

What company makes Digital Blood Pressure Monitor-Wrist Style?

Digital Blood Pressure Monitor-Wrist Style is manufactured by Shenzhen Combei Technology Co., Ltd..

What is the FDA product code for Digital Blood Pressure Monitor-Wrist Style?

The FDA product code for Digital Blood Pressure Monitor-Wrist 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)

Other Devices by Shenzhen Combei Technology Co., Ltd.

K163606Digital Blood Pressure Monitor-Automatic Upper Arm Style K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm 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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