Cleared Traditional

CEREBRALOGIK- AEEG

K131789 · Mennen Medical , Ltd. · Neurology

Dec 2013

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K131789 is an FDA 510(k) clearance for the CEREBRALOGIK- AEEG, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Mennen Medical , Ltd. (Rohovot, IL). The FDA issued a Cleared decision on December 27, 2013, 192 days after receiving the submission on June 18, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K131789 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2013
Decision Date	December 27, 2013
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMA — Amplitude-integrated Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).