Device Classification Name |
Reduced- Montage Standard Electroencephalograph
|
510(k) Number |
K110967 |
Device Name |
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM |
Applicant |
NEURALYNX INC |
105 COMMERCIAL DRIVE |
BOZEMAN,
MT
59715 -2217
|
|
Applicant Contact |
MIKE JOHNSON |
Correspondent |
NEURALYNX INC |
105 COMMERCIAL DRIVE |
BOZEMAN,
MT
59715 -2217
|
|
Correspondent Contact |
MIKE JOHNSON |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 04/06/2011 |
Decision Date | 06/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|