Device Classification Name |
Audiometer
|
510(k) Number |
K930553 |
Device Name |
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT |
Applicant |
ETYMOTIC RESEARCH |
61 MARTIN LN. |
ELK GROVE VILLAGE,
IL
60007
|
|
Applicant Contact |
MEAD C KILLION |
Correspondent |
ETYMOTIC RESEARCH |
61 MARTIN LN. |
ELK GROVE VILLAGE,
IL
60007
|
|
Correspondent Contact |
MEAD C KILLION |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 02/03/1993 |
Decision Date | 09/29/1993 |
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
|
|
|