Device Classification Name |
calibrator, hearing aid / earphone and analysis systems
|
510(k) Number |
K970324 |
Device Name |
GSI SA60 DPOAE SYSTEM |
Applicant |
GRASON-STADLER, INC. |
1 WESTCHESTER DR. |
MILFORD,
NH
03055 -3056
|
|
Applicant Contact |
NORMAN L SCHULTZ |
Correspondent |
GRASON-STADLER, INC. |
1 WESTCHESTER DR. |
MILFORD,
NH
03055 -3056
|
|
Correspondent Contact |
NORMAN L SCHULTZ |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 01/27/1997 |
Decision Date | 06/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|