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FDA 510(k)

BIS™ Advance Monitoring System

K-Number: K230693 · 2024-02-26

ApplicantCovidien, LLC
Decision Date2024-02-26
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS™ Advance Monitoring System is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2024-02-26 under approval number K230693. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIS™ Advance Monitoring System?

BIS™ Advance Monitoring System is a medical device that received FDA 510(k) clearance on 2024-02-26. It is manufactured by Covidien, LLC. The 510(k) number is K230693.

When was BIS™ Advance Monitoring System approved by the FDA?

BIS™ Advance Monitoring System received FDA 510(k) clearance on 2024-02-26, under approval number K230693.

What company makes BIS™ Advance Monitoring System?

BIS™ Advance Monitoring System is manufactured by Covidien, LLC.

What is the FDA product code for BIS™ Advance Monitoring System?

The FDA product code for BIS™ Advance Monitoring System is OLW.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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