Kneu Platform (V2)— 510(k) K262515

Substantially Equivalent

Kneu Health Digital , Ltd.

FDA 510(k) clearance K262515 for Kneu Platform (V2), Substantially Equivalent on 2026-08-20. Applicant: Kneu Health Digital , Ltd.. Device class: 2.

Clearance details

Applicant: Kneu Health Digital , Ltd.
Product code: Code GYD
Device class: Class 2
Regulation: 21 CFR 882.1950
Advisory panel: Neurology
Date received: 2026-07-21
Decision date: 2026-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.