Device Classification Name |
device, biofeedback
|
510(k) Number |
K944615 |
Device Name |
A620 EEG |
Applicant |
STOELTING CO. |
620 WHEAT LN. |
WOOD DALE,
IL
60191
|
|
Applicant Contact |
SAID EL-DINARY |
Correspondent |
STOELTING CO. |
620 WHEAT LN. |
WOOD DALE,
IL
60191
|
|
Correspondent Contact |
SAID EL-DINARY |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 09/20/1994 |
Decision Date | 09/18/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|