Device Classification Name |
audiometer
|
510(k) Number |
K112992 |
Device Name |
EARLOGIC OAE TESTER |
Applicant |
EARLOGIC CORPORATION |
8 EAST BROADWAY |
SUITE 611 |
SALY LAKE CITY,
UT
84111
|
|
Applicant Contact |
SHIN KUK YOO |
Correspondent |
EARLOGIC CORPORATION |
8 EAST BROADWAY |
SUITE 611 |
SALY LAKE CITY,
UT
84111
|
|
Correspondent Contact |
SHIN KUK YOO |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 10/06/2011 |
Decision Date | 04/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|