Cleared Traditional

FACEPLATE ITE HEARING AID MODEL TCA

K910900 · Telex Communications, Inc. · Ear, Nose, Throat
May 1991
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K910900 is an FDA 510(k) clearance for the FACEPLATE ITE HEARING AID MODEL TCA, 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 May 30, 1991, 86 days after receiving the submission on March 5, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number K910900 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1991
Decision Date May 30, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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

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