Cleared Special

Tinnitus Sound Generator Module

K193303 · GN Hearing A/S · Ear, Nose, Throat

Feb 2020

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K193303 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 February 20, 2020, 83 days after receiving the submission on November 29, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K193303 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2019
Decision Date	February 20, 2020
Days to Decision	83 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF