Cleared Traditional

UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID

K946323 · Unitron Industries, Inc. · Ear, Nose, Throat

Jan 1995

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K946323 is an FDA 510(k) clearance for the UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID, 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 30, 1995, 32 days after receiving the submission on December 29, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K946323 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1994
Decision Date	January 30, 1995
Days to Decision	32 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.