Device Classification Name |
Audiometer
|
510(k) Number |
K891373 |
Device Name |
TRACOR RA500 AUDIOMETER |
Applicant |
TRACOR INSTRUMENTS AUSTIN, INC. |
6500 TRACOR LN. |
AUSTIN,
TX
78725
|
|
Applicant Contact |
JACK C FOREMAN |
Correspondent |
TRACOR INSTRUMENTS AUSTIN, INC. |
6500 TRACOR LN. |
AUSTIN,
TX
78725
|
|
Correspondent Contact |
JACK C FOREMAN |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 03/09/1989 |
Decision Date | 07/14/1989 |
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
|
|
|