Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K052981 |
Device Name |
BIS EEG MONITOR, MODEL BISX4 |
Applicant |
ASPECT MEDICAL SYSTEMS, INC. |
141 NEEDHAM ST. |
NEWTON,
MA
02464
|
|
Applicant Contact |
CHRISTINE VOZELLA |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/24/2005 |
Decision Date | 11/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|