Cleared Traditional

PRO-CONNECT

K932269 · Starkey Laboratories, Inc. · Ear, Nose, Throat

May 1994

Decision

367d

Days

Class 1

Risk

About This 510(k) Submission

K932269 is an FDA 510(k) clearance for the PRO-CONNECT, 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 May 13, 1994, 367 days after receiving the submission on May 11, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K932269 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1993
Decision Date	May 13, 1994
Days to Decision	367 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.