Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K040183 |
FOIA Releasable 510(k) |
K040183
|
Device Name |
BISX |
Applicant |
ASPECT MEDICAL SYSTEMS, INC. |
1775 ROCKIES COURT |
LAFAYETTE,
CO
80026
|
|
Applicant Contact |
CHRISTINE VOZELLA |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/27/2004 |
Decision Date | 02/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|