Cleared Traditional

Tinnitus Sound Generator Module

K180495 · GN Hearing A/S · Ear, Nose, Throat
Nov 2018
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K180495 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 November 30, 2018, 277 days after receiving the submission on February 26, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K180495 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2018
Decision Date November 30, 2018
Days to Decision 277 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400