K230693

Substantially Equivalent

BIS Advance Monitoring System

Applicant: Covidien, LLC
Product code: OLW
Advisory panel: Neurology
Date received: 2023-03-13
Decision date: 2024-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.