Cleared Traditional

UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)

K974338 · Unitron Industries, Inc. · Ear, Nose, Throat

Dec 1997

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K974338 is an FDA 510(k) clearance for the UNITRON MODEL F/X PROGRAMMABLE (MINI BTE), 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 December 12, 1997, 24 days after receiving the submission on November 18, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K974338 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1997
Decision Date	December 12, 1997
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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.