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FDA 510(k)

EEG-Now

N.º K: K180524 · 2018-05-18

SolicitanteEncephalodynamics, Inc.
Fecha de decisión2018-05-18
Código de productoGXY
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

EEG-Now is the device name listed in this FDA 510(k) record. The listed applicant is Encephalodynamics, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180524. 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-Now?

EEG-Now is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Encephalodynamics, Inc.. The 510(k) number is K180524.

When did EEG-Now receive FDA 510(k) clearance?

EEG-Now received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180524.

Who is the listed applicant for EEG-Now?

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

What is the FDA product code for EEG-Now?

The FDA product code for EEG-Now is GXY.

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Fuente oficial

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