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FDA 510(k)

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33

K-Number: K211532 · 2022-01-19

ApplicantYibin Junxin Electronics Technology Co., Ltd.
Decision Date2022-01-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is a medical device manufactured by Yibin Junxin Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-19 under approval number K211532. 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, model OB30, OB31, OB32, OB33?

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is a medical device that received FDA 510(k) clearance on 2022-01-19. It is manufactured by Yibin Junxin Electronics Technology Co., Ltd.. The 510(k) number is K211532.

When was Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 approved by the FDA?

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 received FDA 510(k) clearance on 2022-01-19, under approval number K211532.

What company makes Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33?

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is manufactured by Yibin Junxin Electronics Technology Co., Ltd..

What is the FDA product code for Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33?

The FDA product code for Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 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) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Yibin Junxin Electronics Technology Co., Ltd.

K203662Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11

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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