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FDA 510(k)

REMI Remote EEG Monitoring System

K-Number: K243185 · 2025-03-21

ApplicantEpitel
Decision Date2025-03-21
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI Remote EEG Monitoring System is a medical device manufactured by Epitel. It received FDA 510(k) clearance on 2025-03-21 under approval number K243185. 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 2025-03-21. It is manufactured by Epitel. The 510(k) number is K243185.

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

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

What company makes REMI Remote EEG Monitoring System?

REMI Remote EEG Monitoring System is manufactured by Epitel.

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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Related Devices (Code: OMC)

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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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