Cleared Traditional

NIHON KOHDEN AE-918P NEURO UNIT

K130238 · Nihon Kohden Corp. · Neurology

Mar 2015

Decision

762d

Days

Class 2

Risk

About This 510(k) Submission

K130238 is an FDA 510(k) clearance for the NIHON KOHDEN AE-918P NEURO UNIT, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Nihon Kohden Corp. (San Diego, US). The FDA issued a Cleared decision on March 4, 2015, 762 days after receiving the submission on January 31, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K130238 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2013
Decision Date	March 04, 2015
Days to Decision	762 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).