FDA 510(k)

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

Número K: K242326 · 2025-01-02

Data da decisão2025-01-02

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wave Electrode (AE02-60); Wave Electrode (AE02-50) 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 2025-01-02 under 510(k) number K242326. 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 Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Bionit Labs Srl. The 510(k) number is K242326.

When did Wave Electrode (AE02-60); Wave Electrode (AE02-50) receive FDA 510(k) clearance?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K242326.

Who is the listed applicant for Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

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

The FDA product code for Wave Electrode (AE02-60); Wave Electrode (AE02-50) is GXY.

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

K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

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Fonte oficial

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