Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K230693 |
Device Name |
BIS™ Advance Monitoring System |
Applicant |
Covidien LLC |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Applicant Contact |
Moshe J Cohen |
Correspondent |
Covidien LLC |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Correspondent Contact |
Moshe J Cohen |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/13/2023 |
Decision Date | 02/26/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|