Cleared Traditional

TCI (TINNITUS CONTROL INSTRUMENT)

K003559 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat
Apr 2001
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K003559 is an FDA 510(k) clearance for the TCI (TINNITUS CONTROL INSTRUMENT), a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on April 26, 2001, 160 days after receiving the submission on November 17, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K003559 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2000
Decision Date April 26, 2001
Days to Decision 160 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400