Cleared Traditional

SMARTSCREENER-PLUS2

K090579 · Intelligent Hearing Systems · Neurology
Jul 2009
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K090579 is an FDA 510(k) clearance for the SMARTSCREENER-PLUS2, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on July 7, 2009, 126 days after receiving the submission on March 3, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K090579 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2009
Decision Date July 07, 2009
Days to Decision 126 days
Submission Type Traditional
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