Data da decisão2018-05-18
Código do produtoGXY
Comité consultivoNE
DecisãoSubstantially Equivalent
Resumo do 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.
Perguntas frequentes
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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Fonte oficial
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