Cleared Traditional

AM 400

K961084 · Electone, Inc. · Ear, Nose, Throat

Apr 1996

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K961084 is an FDA 510(k) clearance for the AM 400, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on April 18, 1996, 30 days after receiving the submission on March 19, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K961084 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 1996
Decision Date	April 18, 1996
Days to Decision	30 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.