Cleared Special

NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX

K113117 · Nihon Kohden America, Inc. · Neurology

Mar 2012

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K113117 is an FDA 510(k) clearance for the NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on March 22, 2012, 153 days after receiving the submission on October 21, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K113117 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2011
Decision Date	March 22, 2012
Days to Decision	153 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations