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Identevent, Version 1.0G

by Optima Neuroscience, Inc.

510(k) K092039

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092039 Date16 Oct 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMB
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Identevent, Version 1.0g is an Automatic Event Detection Software For Full-Montage Electroencephalograph, classified under the medical specialty of Neurology. It is designed to detect events in retrospective long-term scalp EEG recordings from clinical diagnostic/pre-surgical evaluations. The device is used for seizure detection, evaluating its performance based on sensitivity and false detection rate. The Identevent, Version 1.0g operates as a software solution, providing a tool for healthcare professionals in the field of neurology.

The Identevent, Version 1.0g is supplied as a software product, and its use is restricted by federal law to sale by or on the order of a licensed healthcare practitioner. The device has been cleared under the FDA 510(k) regulatory pathway, with the clearance type being Traditional. It is classified as a Class 2 device, with the regulation number 882.1400. The Identevent, Version 1.0g is associated with the product code OMB and has the k number K092039.

Other devices from Optima Neuroscience, Inc.

  • IdentEvent

    Class II

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Identevent software used for?

    The Identevent software is used for seizure detection in retrospective long-term scalp EEG recordings from clinical diagnostic/pre-surgical evaluations, evaluating its performance based on sensitivity and false detection rate.

  • How is the Identevent software supplied?

    The Identevent software is supplied as a software product, and its use is restricted by federal law to sale by or on the order of a licensed healthcare practitioner.

  • What regulatory pathway was the Identevent software cleared under?

    The Identevent software was cleared under the FDA 510(k) regulatory pathway, with the clearance type being Traditional, and is classified as a Class 2 device.