Cleared Special

ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,

K141446 · Natus Medical Incorporated · Neurology
Aug 2014
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K141446 is an FDA 510(k) clearance for the ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Natus Medical Incorporated (Seattle, US). The FDA issued a Cleared decision on August 22, 2014, 81 days after receiving the submission on June 2, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K141446 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2014
Decision Date August 22, 2014
Days to Decision 81 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900