Cleared Traditional

PRIMOFOCUS COMPACT

K963788 · Oticon Corp. · Ear, Nose, Throat

Nov 1996

Decision

68d

Days

Class 1

Risk

About This 510(k) Submission

K963788 is an FDA 510(k) clearance for the PRIMOFOCUS COMPACT, 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 November 27, 1996, 68 days after receiving the submission on September 20, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K963788 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 1996
Decision Date	November 27, 1996
Days to Decision	68 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.