Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K951507 |
Device Name |
PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE |
Applicant |
NEUROCONCEPTS, INC. |
2135 GREENVIEW DR. |
MIDDLETON,
WI
53562
|
|
Applicant Contact |
HAO QU |
Correspondent |
NEUROCONCEPTS, INC. |
2135 GREENVIEW DR. |
MIDDLETON,
WI
53562
|
|
Correspondent Contact |
HAO QU |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 07/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|