Cleared Traditional

FINETONE DISCEET CANAL

K945780 · Finetone Hearing Instruments · Ear, Nose, Throat

Dec 1994

Decision

26d

Days

Class 1

Risk

About This 510(k) Submission

K945780 is an FDA 510(k) clearance for the FINETONE DISCEET CANAL, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Finetone Hearing Instruments (Scarborough, US). The FDA issued a Cleared decision on December 21, 1994, 26 days after receiving the submission on November 25, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K945780 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 1994
Decision Date	December 21, 1994
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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.