Cleared Traditional

Trex_HD

K162595 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Nov 2016
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K162595 is an FDA 510(k) clearance for the Trex_HD, 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 November 4, 2016, 50 days after receiving the submission on September 15, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K162595 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2016
Decision Date November 04, 2016
Days to Decision 50 days
Submission Type Traditional
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