Cleared Traditional

MODULE PROGRAM

K942722 · Electone, Inc. · Ear, Nose, Throat

Sep 1994

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K942722 is an FDA 510(k) clearance for the MODULE PROGRAM, a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Electone, Inc. (Winter Park, US). The FDA issued a Cleared decision on September 6, 1994, 89 days after receiving the submission on June 9, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K942722 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1994
Decision Date	September 06, 1994
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement