Cleared Traditional

SMARTOAE

K964426 · Intelligent Hearing Systems · Ear, Nose, Throat
Feb 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K964426 is an FDA 510(k) clearance for the SMARTOAE, a Audiometer (Class II — Special Controls, product code EWO), submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on February 3, 1997, 90 days after receiving the submission on November 5, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K964426 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1996
Decision Date February 03, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050