Cleared Special

ELECTRODE JUNCTION BOX, MODEL JE-921A

K050833 · Nihon Kohden America, Inc. · Neurology

Apr 2005

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K050833 is an FDA 510(k) clearance for the ELECTRODE JUNCTION BOX, MODEL JE-921A, 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 April 29, 2005, 28 days after receiving the submission on April 1, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K050833 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2005
Decision Date	April 29, 2005
Days to Decision	28 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.