PHONAK TINNITUS BALANCE— 510(k) K123450

Substantially Equivalent

Phonak, LLC

FDA 510(k) clearance K123450 for PHONAK TINNITUS BALANCE, Substantially Equivalent on 2013-02-11. Applicant: Phonak, LLC. Device class: 2.

Clearance details

Applicant: Phonak, LLC
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2012-11-09
Decision date: 2013-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Warrenville, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLW

K260413 — Levo Gen 2 Tinnitus Therapy System2026-08-13
K260614 — Tinnitus Therapy2026-06-10
K233435 — Peace N Quiet (0.7.0)2024-02-27
K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)2023-06-30
K221168 — Tinnitogram Signal Generator2023-02-01

More clearances from Phonak, LLC

K130790 — LYRIC22013-06-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.