Cleared Special

SMART USBLITE, MODEL M011120

K061443 · Intelligent Hearing Systems · Neurology
Jun 2006
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K061443 is an FDA 510(k) clearance for the SMART USBLITE, MODEL M011120, 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 June 23, 2006, 30 days after receiving the submission on May 24, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K061443 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2006
Decision Date June 23, 2006
Days to Decision 30 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