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FDA 510(k)

Omron Model BP7900 Blood Pressure Monitor + EKG

K-Number: K202228 · 2021-04-01

ApplicantOmron Healthcare, Inc.
Decision Date2021-04-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Omron Model BP7900 Blood Pressure Monitor + EKG is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2021-04-01 under approval number K202228. 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 Omron Model BP7900 Blood Pressure Monitor + EKG?

Omron Model BP7900 Blood Pressure Monitor + EKG is a medical device that received FDA 510(k) clearance on 2021-04-01. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K202228.

When was Omron Model BP7900 Blood Pressure Monitor + EKG approved by the FDA?

Omron Model BP7900 Blood Pressure Monitor + EKG received FDA 510(k) clearance on 2021-04-01, under approval number K202228.

What company makes Omron Model BP7900 Blood Pressure Monitor + EKG?

Omron Model BP7900 Blood Pressure Monitor + EKG is manufactured by Omron Healthcare, Inc..

What is the FDA product code for Omron Model BP7900 Blood Pressure Monitor + EKG?

The FDA product code for Omron Model BP7900 Blood Pressure Monitor + EKG 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: 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)

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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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