Cleared Traditional

NIHON KOHDEN QP-160AK EEG TREND PROGRAM

K092573 · Nihon Kohden America, Inc. · Neurology

Jul 2010

Decision

323d

Days

Class 2

Risk

About This 510(k) Submission

K092573 is an FDA 510(k) clearance for the NIHON KOHDEN QP-160AK EEG TREND PROGRAM, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on July 9, 2010, 323 days after receiving the submission on August 20, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K092573 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2009
Decision Date	July 09, 2010
Days to Decision	323 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).