Cleared Traditional

K984547 - DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
(FDA 510(k) Clearance)

K984547 · Resound Corp. · Ear, Nose, Throat
Mar 1999
Decision
87d
Days
Class 2
Risk

K984547 is an FDA 510(k) clearance for the DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS, a Audiometer (Class II — Special Controls, product code EWO), submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on March 19, 1999, 87 days after receiving the submission on December 22, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K984547 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1998
Decision Date March 19, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050