Cleared Special

Multiflex Tinnitus Technology

K201370 · Starkey Laboratories, Inc. · Ear, Nose, Throat
Jun 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201370 is an FDA 510(k) clearance for the Multiflex Tinnitus Technology, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 19, 2020, 28 days after receiving the submission on May 22, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K201370 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2020
Decision Date June 19, 2020
Days to Decision 28 days
Submission Type Special
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