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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 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.

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. 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.

Other records listing Epitel as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240408REMI-AI Rapid Detection Module (REMI-AI RDM)K231779REMI AI Discrete Detection ModuleK230933REMI Remote EEG Monitoring SystemK203827REMI

Related Devices (Code: OMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.K242306SignalNED System (Model RE)Forest Devices, Inc.

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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