Cleared Special

XLTEK EMU40EX EEG Headbox

K163163 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Dec 2016
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K163163 is an FDA 510(k) clearance for the XLTEK EMU40EX EEG Headbox, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on December 14, 2016, 34 days after receiving the submission on November 10, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K163163 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2016
Decision Date December 14, 2016
Days to Decision 34 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