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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 a medical device manufactured by Aktiia SA. It received FDA 510(k) clearance on 2025-07-02 under approval 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. It is manufactured by Aktiia SA. The 510(k) number is K250415.

When was G0 Blood Pressure Monitoring System (G0) approved by the FDA?

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

What company makes G0 Blood Pressure Monitoring System (G0)?

G0 Blood Pressure Monitoring System (G0) is manufactured by Aktiia SA.

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 Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

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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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