Cleared Traditional

UNITRON MODEL SOUND F/X II

K954516 · Unitron Industries, Inc. · Ear, Nose, Throat

Oct 1995

Decision

Days

Class 1

Risk

About This 510(k) Submission

K954516 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/X II, 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, 9 days after receiving the submission on September 28, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K954516 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 1995
Decision Date	October 07, 1995
Days to Decision	9 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.