A BAER WITH ABAER I/O FUNCTION


Device Classification Name

audiometer

510(k) Number K112247
Device Name A BAER WITH ABAER 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  
Subsequent Product Code
GWJ  
Date Received 08/04/2011
Decision Date 04/02/2012
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