Cleared Traditional

Natus Photic Stimulator

K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Jun 2018
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K173936 is an FDA 510(k) clearance for the Natus Photic Stimulator, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on June 15, 2018, 171 days after receiving the submission on December 26, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K173936 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2017
Decision Date June 15, 2018
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890