Cleared Abbreviated

K123450 - PHONAK TINNITUS BALANCE
(FDA 510(k) Clearance)

K123450 · Phonak, LLC · Ear, Nose, Throat
Feb 2013
Decision
94d
Days
Class 2
Risk

K123450 is an FDA 510(k) clearance for the PHONAK TINNITUS BALANCE. This device is classified as a Masker, Tinnitus (Class II — Special Controls, product code KLW).

Submitted by Phonak, LLC (Warrenville, US). The FDA issued a Cleared decision on February 11, 2013, 94 days after receiving the submission on November 9, 2012.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K123450 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2012
Decision Date February 11, 2013
Days to Decision 94 days
Submission Type Abbreviated
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