FDA.reportPublic FDA data

510(k) K213273

Device
Brain Anesthesia Response Monitor (Bar Monitor)
Applicant
Cortical Dynamics , Ltd.
510(k) number
K213273
Product code
OLW
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-01
Date received
2021-09-30
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
Louis Delacretaz
Address
14 View St. North Perth AU 6006 6006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K052362BIS EEG MONITOR, MODEL A-3000Aspect Medical Systems, Inc.2005-09-09
K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETPhysiometrix, Inc.2005-09-02