FDA 510(k)

MeRT System

Número K: K260402 · 2026-06-03

Data da decisão2026-06-03

Código do produtoSIG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MeRT System is the device name listed in this FDA 510(k) record. The listed applicant is Wave Neuroscience. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260402. The device is classified under product code SIG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MeRT System?

MeRT System is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Wave Neuroscience. The 510(k) number is K260402.

When did MeRT System receive FDA 510(k) clearance?

MeRT System received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260402.

Who is the listed applicant for MeRT System?

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

What is the FDA product code for MeRT System?

The FDA product code for MeRT System is SIG.

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