Cleared Traditional

AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)

K942236 · Audina Hearing Instrument · Ear, Nose, Throat
Jun 1994
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K942236 is an FDA 510(k) clearance for the AUDINA PREWIRES (FACEPLATE HEARING AID SERIES), a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Audina Hearing Instrument (Casselberry, US). The FDA issued a Cleared decision on June 17, 1994, 39 days after receiving the submission on May 9, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number K942236 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1994
Decision Date June 17, 1994
Days to Decision 39 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