Device Classification Name |
Stimulator, Auditory, Evoked Response
|
510(k) Number |
K870030 |
Device Name |
THE SCREENER GSI 55 ABR SCREENER |
Applicant |
GRASON-STADLER, INC. |
537 GREAT RD., P.O. BOX 1400 |
LITTLETON,
MA
01460
|
|
Applicant Contact |
JANICE E PAINTER |
Correspondent |
GRASON-STADLER, INC. |
537 GREAT RD., P.O. BOX 1400 |
LITTLETON,
MA
01460
|
|
Correspondent Contact |
JANICE E PAINTER |
Regulation Number | 882.1900
|
Classification Product Code |
|
Date Received | 01/05/1987 |
Decision Date | 03/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|