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FDA 510(k)

Omron HEM-6400T-Z Wrist Blood Pressure Monitor

K-Number: K163045 · 2017-02-21

ApplicantOmron Healthcare, Inc.
Decision Date2017-02-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-02-21 under approval number K163045. 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 HEM-6400T-Z Wrist Blood Pressure Monitor?

Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K163045.

When was Omron HEM-6400T-Z Wrist Blood Pressure Monitor approved by the FDA?

Omron HEM-6400T-Z Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-21, under approval number K163045.

What company makes Omron HEM-6400T-Z Wrist Blood Pressure Monitor?

Omron HEM-6400T-Z Wrist Blood Pressure Monitor is manufactured by Omron Healthcare, Inc..

What is the FDA product code for Omron HEM-6400T-Z Wrist Blood Pressure Monitor?

The FDA product code for Omron HEM-6400T-Z Wrist 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 Omron Healthcare, Inc.

K162092Evolv Model BP7000 Upper Arm Blood Pressure Monitor K160115Heat Pain Pro K172079Avail K163235HEM-9210T K181992Heat Pain Pro K182481HEM-6410T-ZM Wrist Blood Pressure 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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