Device Classification Name |
Audiometer
|
510(k) Number |
K912669 |
Device Name |
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM |
Applicant |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
JEANNETTE JOHNSON |
Correspondent |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
JEANNETTE JOHNSON |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 06/18/1991 |
Decision Date | 09/16/1991 |
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
|
|
|