Cleared Traditional

qEEG-Pro

K171414 · Brainmaster Technologies, Inc. · Neurology

Jul 2018

Decision

412d

Days

Class 2

Risk

About This 510(k) Submission

K171414 is an FDA 510(k) clearance for the qEEG-Pro, a Normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLU), submitted by Brainmaster Technologies, Inc. (Bedford, US). The FDA issued a Cleared decision on July 1, 2018, 412 days after receiving the submission on May 15, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K171414 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2017
Decision Date	July 01, 2018
Days to Decision	412 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.