Cleared Traditional

UNITRON MODEL IKON AGCO/ AOD

K934565 · Unitron Industries, Inc. · Ear, Nose, Throat

Nov 1993

Decision

74d

Days

Class 1

Risk

About This 510(k) Submission

K934565 is an FDA 510(k) clearance for the UNITRON MODEL IKON AGCO/ AOD, 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 November 29, 1993, 74 days after receiving the submission on September 16, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K934565 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1993
Decision Date	November 29, 1993
Days to Decision	74 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.