BIS Advance pEEG Module— 510(k) K260907
Substantially EquivalentCovidien LP
FDA 510(k) clearance K260907 for BIS Advance pEEG Module, Substantially Equivalent on 2026-08-13. Applicant: Covidien LP. Device class: 2.
Summary
Covidien filed the BIS Advance pEEG Module under product code OLW, index-generating electroencephalograph software. The record doesn't expand BIS or pEEG.
Class II, 21 CFR 882.1400. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Covidien filed from Mansfield, Massachusetts. The decision came 147 calendar days after FDA received it (March 19 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Covidien LP
- Product code
- Product code OLW
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code OLW
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