TCI (TINNITUS CONTROL INSTRUMENT)— 510(k) K003559

Name: FDA 510(k) clearance K003559
Creator: U.S. Food and Drug Administration
Published: 2001-04-26

Substantially Equivalent

Siemens Hearing Instruments, Inc.

FDA 510(k) clearance K003559 for TCI (TINNITUS CONTROL INSTRUMENT), Substantially Equivalent on 2001-04-26. Applicant: Siemens Hearing Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Hearing Instruments, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2000-11-17
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, 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

More clearances from Siemens Hearing Instruments, Inc.

view all

K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)2007-06-05
K011364 — CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)2001-06-07
K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-06-01
K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-04-24
K972998 — PRISMA1997-09-05

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