Cleared Traditional

SMARTEP-ASSR, MODEL M811007

K031051 · Intelligent Hearing Systems · Neurology
Feb 2004
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K031051 is an FDA 510(k) clearance for the SMARTEP-ASSR, MODEL M811007, 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 February 20, 2004, 324 days after receiving the submission on April 2, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K031051 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2003
Decision Date February 20, 2004
Days to Decision 324 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