AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION


Device Classification Name

audiometer

510(k) Number K111618
Device Name AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
Applicant
NATUS MEDICAL INCORPORATED
388 market street
suite 1460
san francisco, 
CA 
94111

Applicant Contact charles l morin
Correspondent
NATUS MEDICAL INCORPORATED
388 market street
suite 1460
san francisco, 
CA 
94111

Correspodent Contact charles l morin
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 06/10/2011
Decision Date 12/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No