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FDA 510(k)

G0 Blood Pressure Monitoring System (G0)

K-Number: K250415 · 2025-07-02

ApplicantAktiia SA
Decision Date2025-07-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

G0 Blood Pressure Monitoring System (G0) is the device name listed in this FDA 510(k) record. The listed applicant is Aktiia SA. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250415. 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 G0 Blood Pressure Monitoring System (G0)?

G0 Blood Pressure Monitoring System (G0) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Aktiia SA. The 510(k) number is K250415.

When did G0 Blood Pressure Monitoring System (G0) receive FDA 510(k) clearance?

G0 Blood Pressure Monitoring System (G0) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250415.

Who is the listed applicant for G0 Blood Pressure Monitoring System (G0)?

The FDA 510(k) record lists Aktiia SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G0 Blood Pressure Monitoring System (G0)?

The FDA product code for G0 Blood Pressure Monitoring System (G0) is DXN.

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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