FDA 510(k)

REMI Remote EEG Monitoring System

Número K: K243185 · 2025-03-21

RequerenteEpitel

Data da decisão2025-03-21

Código do produtoOMC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

REMI Remote EEG Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Epitel. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243185. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REMI Remote EEG Monitoring System?

REMI Remote EEG Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Epitel. The 510(k) number is K243185.

When did REMI Remote EEG Monitoring System receive FDA 510(k) clearance?

REMI Remote EEG Monitoring System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243185.

Who is the listed applicant for REMI Remote EEG Monitoring System?

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

What is the FDA product code for REMI Remote EEG Monitoring System?

The FDA product code for REMI Remote EEG Monitoring System is OMC.

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