Cleared Traditional

DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES

K023459 · Datex-Ohmeda · Neurology

Jan 2003

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K023459 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES, a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on January 13, 2003, 90 days after receiving the submission on October 15, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K023459 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2002
Decision Date	January 13, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
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.