FDA 510(k)

Kneu Platform (V2)

K-Nummer: K262515 · 2026-08-20

Entscheidungsdatum2026-08-20

ProduktcodeGYD

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Kneu Platform (V2) is the device name listed in this FDA 510(k) record. The listed applicant is Kneu Health Digital , Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K262515. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Kneu Platform (V2)?

Kneu Platform (V2) is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Kneu Health Digital , Ltd.. The 510(k) number is K262515.

When did Kneu Platform (V2) receive FDA 510(k) clearance?

Kneu Platform (V2) received FDA 510(k) clearance on 2026-08-20, under 510(k) number K262515.

Who is the listed applicant for Kneu Platform (V2)?

The FDA 510(k) record lists Kneu Health Digital , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kneu Platform (V2)?

The FDA product code for Kneu Platform (V2) is GYD.

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Verwandte Geräte (Code: GYD)

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