Cleared Traditional

MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID

K933579 · Telex Communications, Inc. · Ear, Nose, Throat

Aug 1993

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K933579 is an FDA 510(k) clearance for the MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 23, 1993, 31 days after receiving the submission on July 23, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K933579 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1993
Decision Date	August 23, 1993
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.