Cleared Traditional

AIR CONDUCTION HEARING AID, UNITRON IKON K & KD

K935867 · Unitron Industries, Inc. · Ear, Nose, Throat

Mar 1994

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K935867 is an FDA 510(k) clearance for the AIR CONDUCTION HEARING AID, UNITRON IKON K & KD, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Unitron Industries, Inc. (Port Huron, US). The FDA issued a Cleared decision on March 22, 1994, 106 days after receiving the submission on December 6, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K935867 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 1993
Decision Date	March 22, 1994
Days to Decision	106 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.