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FDA 510(k)

Omron Model BP7900 Blood Pressure Monitor + EKG

K-Number: K182579 · 2019-03-14

ApplicantOmron Healthcare, Inc.
Decision Date2019-03-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Omron Model BP7900 Blood Pressure Monitor + EKG 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 2019-03-14 under 510(k) number K182579. 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 2019-03-14. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K182579.

When did Omron Model BP7900 Blood Pressure Monitor + EKG receive FDA 510(k) clearance?

Omron Model BP7900 Blood Pressure Monitor + EKG received FDA 510(k) clearance on 2019-03-14, under 510(k) number K182579.

Who is the listed applicant for Omron Model BP7900 Blood Pressure Monitor + EKG?

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 Model BP7900 Blood Pressure Monitor + EKG?

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

NCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT07713576Clinical 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 MonitorK182120Maxpower ReliefK182481HEM-6410T-ZM Wrist Blood Pressure MonitorK181992Heat Pain Pro

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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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