Cleared Traditional

BIS? Advance Monitoring System

K230693 · Covidien, LLC · Anesthesiology
Feb 2024
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K230693 is an FDA 510(k) clearance for the BIS? Advance Monitoring System, a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on February 26, 2024, 350 days after receiving the submission on March 13, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K230693 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2023
Decision Date February 26, 2024
Days to Decision 350 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.

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