FDA 510(k)

Comby EEG Caps

Número K: K211315 · 2021-11-09

Data da decisão2021-11-09

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comby EEG Caps is the device name listed in this FDA 510(k) record. The listed applicant is Pamel D.O.O. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211315. 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 Comby EEG Caps?

Comby EEG Caps is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Pamel D.O.O. The 510(k) number is K211315.

When did Comby EEG Caps receive FDA 510(k) clearance?

Comby EEG Caps received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211315.

Who is the listed applicant for Comby EEG Caps?

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

What is the FDA product code for Comby EEG Caps?

The FDA product code for Comby EEG Caps is GXY.

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