Cleared Traditional

Brain Anesthesia Response Monitor (Bar Monitor)

K213273 · Cortical Dynamics , Ltd. · Anesthesiology

Sep 2023

Decision

701d

Days

Class 2

Risk

About This 510(k) Submission

K213273 is an FDA 510(k) clearance for the Brain Anesthesia Response Monitor (Bar Monitor), a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Cortical Dynamics , Ltd. (North Perth, AU). The FDA issued a Cleared decision on September 1, 2023, 701 days after receiving the submission on September 30, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K213273 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2021
Decision Date	September 01, 2023
Days to Decision	701 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	OLW — Index-generating Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.