Cleared Traditional

I81 INITIALES

K862623 · Oticon Corp. · Ear, Nose, Throat

Aug 1986

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K862623 is an FDA 510(k) clearance for the I81 INITIALES, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on August 7, 1986, 28 days after receiving the submission on July 10, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K862623 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1986
Decision Date	August 07, 1986
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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.