Cleared Special

Tinnitus Sound Generator Module

K181586 · GN Hearing A/S · Ear, Nose, Throat

Jul 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K181586 is an FDA 510(k) clearance for the Tinnitus Sound Generator Module, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by GN Hearing A/S (Ballerup, DK). The FDA issued a Cleared decision on July 13, 2018, 28 days after receiving the submission on June 15, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K181586 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2018
Decision Date	July 13, 2018
Days to Decision	28 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF