Cleared Special

NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A

K080546 · Nihon Kohden America, Inc. · Neurology

Aug 2008

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K080546 is an FDA 510(k) clearance for the NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on August 29, 2008, 183 days after receiving the submission on February 28, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K080546 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2008
Decision Date	August 29, 2008
Days to Decision	183 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.