Cleared Traditional

UNITRON MODEL IKON AOHPD

K953727 · Unitron Industries, Inc. · Ear, Nose, Throat

Oct 1995

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K953727 is an FDA 510(k) clearance for the UNITRON MODEL IKON AOHPD, 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 October 7, 1995, 58 days after receiving the submission on August 10, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K953727 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 1995
Decision Date	October 07, 1995
Days to Decision	58 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.