FDA 510(k)

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

Número K: K260453 · 2026-03-12

Data da decisão2026-03-12

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is the device name listed in this FDA 510(k) record. The listed applicant is Bionit Labs Srl. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K260453. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Bionit Labs Srl. The 510(k) number is K260453.

When did Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) receive FDA 510(k) clearance?

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K260453.

Who is the listed applicant for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

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

What is the FDA product code for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

The FDA product code for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is GXY.

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Outros registros que listam Bionit Labs Srl como candidato(a)

K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)

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Fonte oficial

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