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FDA 510(k)

Digital Blood Pressure Monitor-Wrist Style

K-Number: K171833 · 2018-01-10

ApplicantShenzhen Combei Technology Co., Ltd.
Decision Date2018-01-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor-Wrist Style is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K171833. 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 Digital Blood Pressure Monitor-Wrist Style?

Digital Blood Pressure Monitor-Wrist Style is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K171833.

When did Digital Blood Pressure Monitor-Wrist Style receive FDA 510(k) clearance?

Digital Blood Pressure Monitor-Wrist Style received FDA 510(k) clearance on 2018-01-10, under 510(k) number K171833.

Who is the listed applicant for Digital Blood Pressure Monitor-Wrist Style?

The FDA 510(k) record lists Shenzhen Combei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Blood Pressure Monitor-Wrist Style?

The FDA product code for Digital Blood Pressure Monitor-Wrist Style 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 Shenzhen Combei Technology Co., Ltd. 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.

K202741Infrared Forehead ThermometerK181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleK163606Digital Blood Pressure Monitor-Automatic Upper Arm Style

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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