Device Classification Name |
audiometer
|
510(k) Number |
K884044 |
Device Name |
AUDIOMETER DIGITAL HEARING SYSTEM |
Applicant |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
VINCENT PLUVINAGE |
Correspondent |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
VINCENT PLUVINAGE |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 09/26/1988 |
Decision Date | 02/22/1989 |
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
|
|
|