FDA 510(k)

EEG Electrode Template

N.º K: K191225 · 2019-08-05

SolicitanteRhythmlink International, LLC

Fecha de decisión2019-08-05

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

EEG Electrode Template is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K191225. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EEG Electrode Template?

EEG Electrode Template is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K191225.

When did EEG Electrode Template receive FDA 510(k) clearance?

EEG Electrode Template received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191225.

Who is the listed applicant for EEG Electrode Template?

The FDA 510(k) record lists Rhythmlink International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEG Electrode Template?

The FDA product code for EEG Electrode Template is GXY.

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Otros registros que enlistan a Rhythmlink International, LLC como solicitante

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Dispositivos relacionados (Código: GXY)

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Fuente oficial

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