Cleared Traditional

SMARTTROAE

K023859 · Intelligent Hearing Systems · Ear, Nose, Throat
Jan 2003
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K023859 is an FDA 510(k) clearance for the SMARTTROAE, a Audiometer (Class II — Special Controls, product code EWO), submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on January 8, 2003, 49 days after receiving the submission on November 20, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K023859 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2002
Decision Date January 08, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

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