TITAN


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K103760
Device Name TITAN
Applicant
INTERACOUSTICS A/S
drejervaenget 8
assens, 

DK

dk-5610

Applicant Contact erik nielsen
Correspondent
INTERACOUSTICS A/S
drejervaenget 8
assens, 

DK

dk-5610

Correspodent Contact erik nielsen
Regulation Number 882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received 12/23/2010
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No