SWITCH TRT— 510(k) K091552

Substantially Equivalent

Audifon GmbH & Co. KG

FDA 510(k) clearance K091552 for SWITCH TRT, Substantially Equivalent on 2009-08-12. Applicant: Audifon GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Audifon GmbH & Co. KG
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2009-05-27
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Debary, FL, 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

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