Cleared Traditional

K974257 - RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
(FDA 510(k) Clearance)

K974257 · Resound Corp. · Ear, Nose, Throat

Dec 1997

Decision

29d

Days

Class 1

Risk

K974257 is an FDA 510(k) clearance for the RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER). This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD).

Submitted by Resound Corp. (Greeley, US). The FDA issued a Cleared decision on December 12, 1997, 29 days after receiving the submission on November 13, 1997.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3300. 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..

Submission Details

510(k) Number	K974257 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1997
Decision Date	December 12, 1997
Days to Decision	29 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.