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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2024-02-26 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K230693.

When did BIS™ Advance Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for BIS™ Advance Monitoring System?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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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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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