Cleared Traditional

ST 20 PORTABLE AUDIOMETER

K922746 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Nov 1992
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K922746 is an FDA 510(k) clearance for the ST 20 PORTABLE AUDIOMETER, a Audiometer (Class II — Special Controls, product code EWO), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 5, 1992, 150 days after receiving the submission on June 8, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K922746 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1992
Decision Date November 05, 1992
Days to Decision 150 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