CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)


Device Classification Name

masker, tinnitus

510(k) Number K011364
Device Name CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
Original Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 constitution ave.
p.o. box 1397
piscataway, 
NJ 
08855

Original Contact dave slavin
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 05/04/2001
Decision Date 06/07/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No