Cleared Traditional

SMART-SCREENER (AUDITORY)

K925648 · Intelligent Hearing Systems · Neurology
May 1993
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K925648 is an FDA 510(k) clearance for the SMART-SCREENER (AUDITORY), 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 May 11, 1993, 183 days after receiving the submission on November 9, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K925648 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1992
Decision Date May 11, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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