CUSTOMIZED SOUND THERAPY (CST)— 510(k) K070599

Name: FDA 510(k) clearance K070599
Creator: U.S. Food and Drug Administration
Published: 2007-07-13

Substantially Equivalent

Tinnitus Otosound Products, LLC

FDA 510(k) clearance K070599 for CUSTOMIZED SOUND THERAPY (CST), Substantially Equivalent on 2007-07-13. Applicant: Tinnitus Otosound Products, LLC. Device class: 2.

Clearance details

Applicant: Tinnitus Otosound Products, LLC
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2007-03-02
Decision date: 2007-07-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLW

view all

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

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