Cleared Traditional

WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES

K033475 · Nihon Kohden America, Inc. · Neurology

Jan 2004

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K033475 is an FDA 510(k) clearance for the WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES, 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 7, 2004, 65 days after receiving the submission on November 3, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K033475 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2003
Decision Date	January 07, 2004
Days to Decision	65 days
Submission Type	Traditional
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.