Cleared Traditional

Natus Brain Monitor Amplifier

K180290 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Jun 2018
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K180290 is an FDA 510(k) clearance for the Natus Brain Monitor Amplifier, 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 June 14, 2018, 133 days after receiving the submission on February 1, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K180290 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2018
Decision Date June 14, 2018
Days to Decision 133 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