FDA 510(k)

KBA3D (v2.4.0)

Número K: K261500 · 2026-08-17

RequerenteS.M.A.I.O

Data da decisão2026-08-17

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

KBA3D (v2.4.0) is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2026-08-17 under 510(k) number K261500. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KBA3D (v2.4.0)?

KBA3D (v2.4.0) is a medical device that received FDA 510(k) clearance on 2026-08-17. The listed applicant is S.M.A.I.O. The 510(k) number is K261500.

When did KBA3D (v2.4.0) receive FDA 510(k) clearance?

KBA3D (v2.4.0) received FDA 510(k) clearance on 2026-08-17, under 510(k) number K261500.

Who is the listed applicant for KBA3D (v2.4.0)?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KBA3D (v2.4.0)?

The FDA product code for KBA3D (v2.4.0) is LLZ.

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Fonte oficial

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