Cleared Traditional

EUROSTAR SUPER, EUROSTAR VFC

K942036 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Jun 1994

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K942036 is an FDA 510(k) clearance for the EUROSTAR SUPER, EUROSTAR VFC, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 24, 1994, 57 days after receiving the submission on April 28, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K942036 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1994
Decision Date	June 24, 1994
Days to Decision	57 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.