Device Classification Name |
Audiometer
|
510(k) Number |
K122496 |
Device Name |
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM |
Applicant |
BIO-LOGIC SYSTEMS CORP. |
ONE BIOLOGIC PLAZA |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
TIMOTHY KARLOVSKY |
Correspondent |
BIO-LOGIC SYSTEMS CORP. |
ONE BIOLOGIC PLAZA |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
TIMOTHY KARLOVSKY |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 11/01/2012 |
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
|
|
|