IDENTEVENT, VERSION 1.0G— 510(k) K092039

Name: FDA 510(k) clearance K092039
Creator: U.S. Food and Drug Administration
Published: 2009-10-16

Substantially Equivalent

Optima Neuroscience, Inc.

FDA 510(k) clearance K092039 for IDENTEVENT, VERSION 1.0G, Substantially Equivalent on 2009-10-16. Applicant: Optima Neuroscience, Inc.. Device class: 2.

Clearance details

Applicant: Optima Neuroscience, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-07-06
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newberry, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMB

view all

K260998 — Ceribell Neurology Review Software2026-06-24
K252070 — Ceribell Infant Seizure Detection Software2025-11-21
K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))2025-10-31
K241589 — Ceribell Seizure Detection Software2025-04-09
K243743 — autoSCORE (V 2.0.0)2025-04-09

More clearances from Optima Neuroscience, Inc.

view all

K150688 — IdentEvent2015-11-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.