Cleared Traditional

AM 260 OHM

K953054 · Electone, Inc. · Ear, Nose, Throat

Aug 1995

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K953054 is an FDA 510(k) clearance for the AM 260 OHM, 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 August 15, 1995, 46 days after receiving the submission on June 30, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K953054 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1995
Decision Date	August 15, 1995
Days to Decision	46 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.