Cleared Traditional

CNS Envision

K192572 · Moberg Research, Inc. · Neurology

Dec 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K192572 is an FDA 510(k) clearance for the CNS Envision, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Moberg Research, Inc. (Ambler, US). The FDA issued a Cleared decision on December 17, 2019, 90 days after receiving the submission on September 18, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K192572 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2019
Decision Date	December 17, 2019
Days to Decision	90 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.