Cleared Special

EEG-1100A SWITCH BOX

K073491 · Nihon Kohden America, Inc. · Neurology

Jan 2008

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K073491 is an FDA 510(k) clearance for the EEG-1100A SWITCH BOX, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on January 11, 2008, 30 days after receiving the submission on December 12, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K073491 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2007
Decision Date	January 11, 2008
Days to Decision	30 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLV — Standard Polysomnograph With Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.