Cleared Traditional

Wireless EEG System

K213299 · Pascall Systems, Inc. · Neurology

May 2022

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K213299 is an FDA 510(k) clearance for the Wireless EEG System, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Pascall Systems, Inc. (Boston, US). The FDA issued a Cleared decision on May 11, 2022, 222 days after receiving the submission on October 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K213299 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2021
Decision Date	May 11, 2022
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.