Cleared Traditional

ARTISAN PROGRAMMER & HEARING AID

K935048 · Telex Communications, Inc. · Ear, Nose, Throat
Feb 1994
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K935048 is an FDA 510(k) clearance for the ARTISAN PROGRAMMER & HEARING AID, a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 9, 1994, 111 days after receiving the submission on October 21, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number K935048 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1993
Decision Date February 09, 1994
Days to Decision 111 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code LRB — Face Plate Hearing Aid
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.3300