FDA 510(k)

REMI

K-Number: K203827 · 2021-03-29

Decision Date2021-03-29

Product CodeOMC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

REMI is the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2021-03-29 under 510(k) number K203827. 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?

REMI is a medical device that received FDA 510(k) clearance on 2021-03-29. The listed applicant is Epitel, Inc.. The 510(k) number is K203827.

When did REMI receive FDA 510(k) clearance?

REMI received FDA 510(k) clearance on 2021-03-29, under 510(k) number K203827.

Who is the listed applicant for REMI?

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

What is the FDA product code for REMI?

The FDA product code for REMI is OMC.

Other records listing Epitel, Inc. 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.

K243185REMI Remote EEG Monitoring System K240408REMI-AI Rapid Detection Module (REMI-AI RDM)K231779REMI AI Discrete Detection Module K230933REMI Remote EEG Monitoring System

Related Devices (Code: OMC)

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies Sas K251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitel K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

Official Source

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