Cleared Traditional

K081551 - TWIN NEUROTRAC-III
(FDA 510(k) Clearance)

K081551 · Astro-Med, Inc. · Neurology

Dec 2008

Decision

204d

Days

Class 2

Risk

K081551 is an FDA 510(k) clearance for the TWIN NEUROTRAC-III. This device is classified as a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA).

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on December 24, 2008, 204 days after receiving the submission on June 3, 2008.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. 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)..

Submission Details

510(k) Number	K081551 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2008
Decision Date	December 24, 2008
Days to Decision	204 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).