Device Classification Name |
index-generating electroencephalograph software
|
510(k) Number |
K010965 |
Device Name |
A-LINE AEP MONITOR |
Applicant |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RENEE FLUET |
Correspondent |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RENEE FLUET |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/02/2001 |
Decision Date | 06/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|