Tinnitus Sound Generator Module— 510(k) K150171

Substantially Equivalent

Gn Resound A/S

FDA 510(k) clearance K150171 for Tinnitus Sound Generator Module, Substantially Equivalent on 2015-05-14. Applicant: Gn Resound A/S. Device class: 2.

Clearance details

Applicant: Gn Resound A/S
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-26
Decision date: 2015-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Ballerup, DK

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 Gn Resound A/S

K110932 — TINNITUS SOUND GENERATOR MODULE2011-05-03
K073636 — TINNITUS SOUND GENERATOR MODULE2008-03-13

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