Cleared Traditional

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

K223694 · Duearity AB · Ear, Nose, Throat

Jun 2023

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K223694 is an FDA 510(k) clearance for the Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042), a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Duearity AB (Malmo, SE). The FDA issued a Cleared decision on June 30, 2023, 203 days after receiving the submission on December 9, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K223694 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2022
Decision Date	June 30, 2023
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF