510(k) K230693

Device
BIS? Advance Monitoring System
Applicant
Covidien, LLC
510(k) number
K230693
Product code
OLW
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-26
Date received
2023-03-13
Regulation
882.1400
Classification name
Index-Generating Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Moshe J Cohen
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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