Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K974496 |
Device Name |
A-2000 EEG MONITOR WITH BIS |
Applicant |
ASPECT MEDICAL SYSTEMS, INC. |
2 VISION DR. |
NATICK,
MA
01760 -2059
|
|
Applicant Contact |
CHRISTINE MORGIDA |
Correspondent |
ASPECT MEDICAL SYSTEMS, INC. |
2 VISION DR. |
NATICK,
MA
01760 -2059
|
|
Correspondent Contact |
CHRISTINE MORGIDA |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/28/1997 |
Decision Date | 02/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|