Cleared Special

NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P

K120485 · Nihon Kohden America, Inc. · Neurology

Mar 2012

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K120485 is an FDA 510(k) clearance for the NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P, 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 March 16, 2012, 28 days after receiving the submission on February 17, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K120485 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2012
Decision Date	March 16, 2012
Days to Decision	28 days
Submission Type	Special
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).