Device Classification Name |
Reduced- Montage Standard Electroencephalograph
|
510(k) Number |
K060523 |
Device Name |
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM |
Applicant |
CYBERKINETICS, INC. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary Syring |
Correspondent |
CYBERKINETICS, INC. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 02/27/2006 |
Decision Date | 03/28/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|