Cleared Traditional

CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

K011366 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Jun 2001

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K011366 is an FDA 510(k) clearance for the CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION), 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 1, 2001, 28 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	K011366 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2001
Decision Date	June 01, 2001
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF