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FDA 510(k)

REMI Remote EEG Monitoring System

K-Number: K230933 · 2023-06-30

ApplicantEpitel, Inc.
Decision Date2023-06-30
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI Remote EEG Monitoring System is a medical device manufactured by Epitel, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K230933. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMI Remote EEG Monitoring System?

REMI Remote EEG Monitoring System is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Epitel, Inc.. The 510(k) number is K230933.

When was REMI Remote EEG Monitoring System approved by the FDA?

REMI Remote EEG Monitoring System received FDA 510(k) clearance on 2023-06-30, under approval number K230933.

What company makes REMI Remote EEG Monitoring System?

REMI Remote EEG Monitoring System is manufactured by Epitel, Inc..

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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Related PubMed Literature

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Other Devices by Epitel, Inc.

K203827REMI K240408REMI-AI Rapid Detection Module (REMI-AI RDM) K231779REMI AI Discrete Detection Module

Related Devices (Code: OMC)

K170363Ceribell Pocket EEG DeviceCeribell, Inc. K183529AE-120A EEG Head SetNihon Kohden Corporation K192549Byteflies KitByteflies NV K203827REMIEpitel, Inc. K221563Neurosteer EEG RecorderNeurosteer, Inc. K223628NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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