Cleared Traditional

KS 5 - CLINICAL AUDIOMETER

K931322 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Aug 1994
Decision
521d
Days
Class 2
Risk

About This 510(k) Submission

K931322 is an FDA 510(k) clearance for the KS 5 - CLINICAL 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 August 19, 1994, 521 days after receiving the submission on March 16, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K931322 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1993
Decision Date August 19, 1994
Days to Decision 521 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