Cleared Traditional

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

K011364 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat
Jun 2001
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K011364 is an FDA 510(k) clearance for the CUSTOM 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 June 7, 2001, 34 days after receiving the submission on May 4, 2001. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K011364 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2001
Decision Date June 07, 2001
Days to Decision 34 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