Cleared Traditional

Entropy Module, E-ENTROPY-01

K150298 · Ge Healthcare Filand OY · Neurology

Nov 2015

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K150298 is an FDA 510(k) clearance for the Entropy Module, E-ENTROPY-01, a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Ge Healthcare Filand OY (Helsinki, FI). The FDA issued a Cleared decision on November 12, 2015, 279 days after receiving the submission on February 6, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K150298 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2015
Decision Date	November 12, 2015
Days to Decision	279 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.