Device Classification Name |
non-normalizing quantitative electroencephalograph software
|
510(k) Number |
K934050 |
Device Name |
TOPOGRAPHIC BRAIN MAPPING OPTION |
Applicant |
BIOSOUND, INC. |
7990 CASTLEWAY DR. |
P.O. BOX 50867 |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
WAYNE L NETHERCUTT |
Correspondent |
BIOSOUND, INC. |
7990 CASTLEWAY DR. |
P.O. BOX 50867 |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
WAYNE L NETHERCUTT |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/19/1993 |
Decision Date | 02/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|