Device Classification Name |
audiometer
|
510(k) Number |
K112733 |
Device Name |
ER35 ERO-SCAN PRO HEARING TEST SYSTEM |
Applicant |
ETYMOTIC RESEARCH, INC. |
2001 PENNSYLVANIA AVE. NW |
SUITE 950 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
JACK KENT |
Correspondent |
ETYMOTIC RESEARCH, INC. |
2001 PENNSYLVANIA AVE. NW |
SUITE 950 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
JACK KENT |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2011 |
Decision Date | 12/16/2011 |
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
|
|
|