Cleared Traditional

BrainView QEEG Software

K212684 · Medeia, Inc. · Neurology

Jan 2023

Decision

522d

Days

Class 2

Risk

About This 510(k) Submission

K212684 is an FDA 510(k) clearance for the BrainView QEEG Software, a Normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLU), submitted by Medeia, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on January 28, 2023, 522 days after receiving the submission on August 24, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K212684 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2021
Decision Date	January 28, 2023
Days to Decision	522 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLU — Normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.