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FDA 510(k)

BIS™ Advance pEEG Module

K-Number: K260907 · 2026-08-13

ApplicantCovidien LP
Decision Date2026-08-13
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS™ Advance pEEG Module is the device name listed in this FDA 510(k) record. The listed applicant is Covidien LP. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K260907. 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 pEEG Module?

BIS™ Advance pEEG Module is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Covidien LP. The 510(k) number is K260907.

When did BIS™ Advance pEEG Module receive FDA 510(k) clearance?

BIS™ Advance pEEG Module received FDA 510(k) clearance on 2026-08-13, under 510(k) number K260907.

Who is the listed applicant for BIS™ Advance pEEG Module?

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

What is the FDA product code for BIS™ Advance pEEG Module?

The FDA product code for BIS™ Advance pEEG Module is OLW.

Other records listing Covidien LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.K172890SedLine Sedation MonitorMasimo Corporation

Official Source

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

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