Cleared Traditional

UNITRON MODEL IKON AOHPL

K953646 · Unitron Industries, Inc. · Ear, Nose, Throat

Aug 1995

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K953646 is an FDA 510(k) clearance for the UNITRON MODEL IKON AOHPL, 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 August 28, 1995, 24 days after receiving the submission on August 4, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K953646 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 1995
Decision Date	August 28, 1995
Days to Decision	24 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.