Cleared Traditional

SMARTEP, MODEL M010000

K070608 · Intelligent Hearing Systems · Neurology
Jul 2007
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K070608 is an FDA 510(k) clearance for the SMARTEP, MODEL M010000, 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 18, 2007, 135 days after receiving the submission on March 5, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K070608 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2007
Decision Date July 18, 2007
Days to Decision 135 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