Cleared Traditional

SMART-EP

K904926 · Intelligent Hearing Systems · Neurology
Aug 1991
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K904926 is an FDA 510(k) clearance for the SMART-EP, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on August 2, 1991, 275 days after receiving the submission on October 31, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K904926 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1990
Decision Date August 02, 1991
Days to Decision 275 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900