Cleared Traditional

UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)

K970519 · Unitron Industries, Inc. · Ear, Nose, Throat

Apr 1997

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K970519 is an FDA 510(k) clearance for the UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE), 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 April 24, 1997, 72 days after receiving the submission on February 11, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K970519 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1997
Decision Date	April 24, 1997
Days to Decision	72 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.