Cleared Traditional

UNITRON MODEL SOUNG F/S

K946264 · Unitron Industries, Inc. · Ear, Nose, Throat

Jan 1995

Decision

34d

Days

Class 1

Risk

About This 510(k) Submission

K946264 is an FDA 510(k) clearance for the UNITRON MODEL SOUNG F/S, 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 January 26, 1995, 34 days after receiving the submission on December 23, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K946264 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1994
Decision Date	January 26, 1995
Days to Decision	34 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.