Cleared Traditional

GOLD AF MODULE, ITE

K933038 · Electone, Inc. · Ear, Nose, Throat

Aug 1993

Decision

96d

Days

Class 1

Risk

About This 510(k) Submission

K933038 is an FDA 510(k) clearance for the GOLD AF MODULE, ITE, a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on August 2, 1993, 96 days after receiving the submission on April 28, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K933038 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1993
Decision Date	August 02, 1993
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement