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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 the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K163045.

When did Omron HEM-6400T-Z Wrist Blood Pressure Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Omron HEM-6400T-Z Wrist Blood Pressure Monitor?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Other records listing Omron Healthcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202228Omron Model BP7900 Blood Pressure Monitor + EKGK183215Focus TENS Therapy, Model PM710-M/-LK190693HEM-6410T-ZL Wrist Blood Pressure MonitorK182579Omron Model BP7900 Blood Pressure Monitor + EKGK182120Maxpower ReliefK182481HEM-6410T-ZM Wrist Blood Pressure Monitor

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

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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