Device Classification Name |
analyzer, spectrum, electroencephalogram signal
|
510(k) Number |
K871931 |
Device Name |
ISTAT SOFTWARE |
Applicant |
NEUROSCIENCE, INC. |
210 TOPAZ ST. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
MICHAEL R MORAN |
Correspondent |
NEUROSCIENCE, INC. |
210 TOPAZ ST. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
MICHAEL R MORAN |
Regulation Number | 882.1420
|
Classification Product Code |
|
Date Received | 05/19/1987 |
Decision Date | 10/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|