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FDA 510(k)

Blood Pressure Monitor

K-Number: K162089 · 2017-02-10

ApplicantBeijing Choice Electronic Technology Co., Ltd.
Decision Date2017-02-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Blood Pressure Monitor is a medical device manufactured by Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-10 under approval number K162089. 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 Blood Pressure Monitor?

Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K162089.

When was Blood Pressure Monitor approved by the FDA?

Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-10, under approval number K162089.

What company makes Blood Pressure Monitor?

Blood Pressure Monitor is manufactured by Beijing Choice Electronic Technology Co., Ltd..

What is the FDA product code for Blood Pressure Monitor?

The FDA product code for 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 Beijing Choice Electronic Technology Co., Ltd.

K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51 K161560Fingertip Pulse Oximeter MD300CN310 K152563Pulse Oximeter (MD300M/MD300K2) K181503Fingertip Pulse Oximeter K172366Wrist Pulse Oximeter K211754Vital Signs Monitor

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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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