Cleared Traditional

Natus Quantum

K143440 · Natus Medical Incorporated · Neurology
Apr 2015
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K143440 is an FDA 510(k) clearance for the Natus Quantum, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Natus Medical Incorporated (Oakville, CA). The FDA issued a Cleared decision on April 20, 2015, 139 days after receiving the submission on December 2, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K143440 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2014
Decision Date April 20, 2015
Days to Decision 139 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