Cleared Special

PSG-1100 SLEEP DIAGNOSTIC SYSTEM

K120888 · Nihon Kohden Corp. · Neurology

Nov 2012

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K120888 is an FDA 510(k) clearance for the PSG-1100 SLEEP DIAGNOSTIC SYSTEM, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on November 9, 2012, 231 days after receiving the submission on March 23, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K120888 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2012
Decision Date	November 09, 2012
Days to Decision	231 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations