Device Classification Name |
audiometer
|
510(k) Number |
K880059 |
Device Name |
AMPLAID 309 CLINICAL AUDIOMETER |
Applicant |
AMPLUS CORP. |
65 BRISTLECONE WAY |
BOULDER,
CO
80304
|
|
Applicant Contact |
MARGARET MIZZONI |
Correspondent |
AMPLUS CORP. |
65 BRISTLECONE WAY |
BOULDER,
CO
80304
|
|
Correspondent Contact |
MARGARET MIZZONI |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 01/07/1988 |
Decision Date | 02/23/1988 |
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
|
|
|