Brain Anesthesia Response Monitor (Bar Monitor)— 510(k) K213273

Name: FDA 510(k) clearance K213273
Creator: U.S. Food and Drug Administration
Published: 2023-09-01

Substantially Equivalent

Cortical Dynamics , Ltd.

FDA 510(k) clearance K213273 for Brain Anesthesia Response Monitor (Bar Monitor), Substantially Equivalent on 2023-09-01. Applicant: Cortical Dynamics , Ltd.. Device class: 2.

Clearance details

Applicant: Cortical Dynamics , Ltd.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2021-09-30
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Perth, AU

Download summary PDF View on FDA.gov ↗

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