TEOAE25


Device Classification Name

audiometer

510(k) Number K030016
Device Name TEOAE25
Original Applicant
INTERACOUSTICS A/S, ASSENS
9675 west 76th st.
eden prairie, 
MN 
55344

Original Contact daniel eggan
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 01/02/2003
Decision Date 03/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No