Cleared Traditional

SMART COUPLER, MODEL M015401

K073384 · Intelligent Hearing Systems · Neurology
Feb 2008
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K073384 is an FDA 510(k) clearance for the SMART COUPLER, MODEL M015401, 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 28, 2008, 87 days after receiving the submission on December 3, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K073384 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2007
Decision Date February 28, 2008
Days to Decision 87 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