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FDA 510(k)

REMI

K-Number: K203827 · 2021-03-29

ApplicantEpitel, Inc.
Decision Date2021-03-29
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI is a medical device manufactured by Epitel, Inc.. It received FDA 510(k) clearance on 2021-03-29 under approval 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. It is manufactured by Epitel, Inc.. The 510(k) number is K203827.

When was REMI approved by the FDA?

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

What company makes REMI?

REMI is manufactured by Epitel, Inc..

What is the FDA product code for REMI?

The FDA product code for REMI is OMC.

Other Devices by Epitel, Inc.

K230933REMI Remote EEG Monitoring System 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 K221563Neurosteer EEG RecorderNeurosteer, Inc. K230933REMI Remote EEG Monitoring SystemEpitel, 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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