Device Classification Name |
Audiometer
|
510(k) Number |
K994033 |
Device Name |
HORTMANN ECHOMASTER OAE ANALYZER |
Applicant |
HORTMANN AG |
P.O. BOX 1119 |
DRIPPING SPRINGS,
TX
78620
|
|
Applicant Contact |
BRADFORD MELANCON |
Correspondent |
HORTMANN AG |
P.O. BOX 1119 |
DRIPPING SPRINGS,
TX
78620
|
|
Correspondent Contact |
BRADFORD MELANCON |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 11/26/1999 |
Decision Date | 02/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|