Device Classification Name |
Audiometer
|
510(k) Number |
K883505 |
Device Name |
BIOMETER AUDIOMETER |
Applicant |
MICRO AUDIOMETRICS CORP. |
3749-B S. NOVA RD. |
PORT ORANGE,
FL
32129 -4233
|
|
Applicant Contact |
KATHLEEN A KELLER |
Correspondent |
MICRO AUDIOMETRICS CORP. |
3749-B S. NOVA RD. |
PORT ORANGE,
FL
32129 -4233
|
|
Correspondent Contact |
KATHLEEN A KELLER |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 08/17/1988 |
Decision Date | 08/21/1989 |
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
|
|
|