Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K874733 |
Device Name |
GUARDIAN, EEG BRAIN MONITORING SYSTEM |
Applicant |
TRACOR NORTHERN, INC. |
2551 WEST BELTLINE HWY |
MIDDLETON,
WI
53562
|
|
Applicant Contact |
KENNETH R WINDISCH |
Correspondent |
TRACOR NORTHERN, INC. |
2551 WEST BELTLINE HWY |
MIDDLETON,
WI
53562
|
|
Correspondent Contact |
KENNETH R WINDISCH |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/18/1987 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|