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FDA 510(k)

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

K-Number: K211288 · 2021-11-04

ApplicantMicrolife Intellectual Property GmbH
Decision Date2021-11-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K211288. 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 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211288.

When did Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B receive FDA 510(k) clearance?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B received FDA 510(k) clearance on 2021-11-04, under 510(k) number K211288.

Who is the listed applicant for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B 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.

NCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETEDNCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT07633886Multi-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_RECRUITING

Other records listing Microlife Intellectual Property GmbH as applicant

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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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