510(k) K230693
K230693 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "BIS Advance Monitoring System". The FDA issued a decision of Substantially Equivalent on February 26, 2024. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2024
- Date Received
- March 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Index-Generating Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.