BIS Advance Monitoring System
FDA 510(k) K230693 · Covidien, LLC
510(k) numberK230693
Submission
- Device name
- BIS Advance Monitoring System
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- March 13, 2023
- Decision date
- February 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLW – Index-Generating Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Other 510(k)s with product code OLW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | Covidien LP | 08/13/2026SE |
| K260880 | SedLine Sedation MonitorOLW · Traditional | Masimo Corporation | 07/10/2026SE |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor)OLW · Traditional | Cortical Dynamics , Ltd. | 09/01/2023SE |
| K203113 | Masimo SedLine Sedation Monitor and AccessoriesOLW · Traditional | Masimo Corporation | 02/25/2022SE |
| K202621 | NeuroSENSE Monitoring System, Model NS-901OLW · Traditional | Neurowave Systems, Inc. | 08/05/2021SE |
| K172890 | SedLine Sedation MonitorOLW · Traditional | Masimo Corporation | 01/26/2018SE |
| K150298 | Entropy Module, E-ENTROPY-01OLW · Traditional | Ge Healthcare Filand OY | 11/12/2015SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | Mennen Medical , Ltd. | 12/16/2008SE |
| K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesOLW · Traditional | GE Healthcare | 03/27/2008SE |
| K072286 | Bis EEG Vista Monitor System and BisxOLW · Traditional | Aspect Medical Systems, Inc. | 11/20/2007SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | 08/13/2026SE |
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Questions and answers
When was BIS Advance Monitoring System cleared by the FDA?
BIS Advance Monitoring System (K230693) received a 510(k) decision of Substantially Equivalent on February 26, 2024, 350 days after the submission was received.
What is the product code of K230693?
The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.