Bis Module for Envoy Patient Monitor
FDA 510(k) K071899 · Mennen Medical , Ltd.
510(k) numberK071899
Submission
- Device name
- Bis Module for Envoy Patient Monitor
- Applicant
- Mennen Medical , Ltd.
Rohovot, IL - Received
- July 9, 2007
- Decision date
- October 22, 2007
- 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.
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| K260880 | SedLine Sedation MonitorOLW · Traditional | Masimo Corporation | 07/10/2026SE |
| K230693 | BIS Advance Monitoring SystemOLW · Traditional | Covidien, LLC | 02/26/2024SE |
| 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 |
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| K123792 | Horizon Xvu (FFR)DQX · Traditional | 08/30/2013SE |
| K093766 | Vitalogik 6000/6500DSI · Special | 05/07/2010SE |
| K091165 | Horizon XvuDQK · Traditional | 08/07/2009SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | 12/16/2008SE |
| K081484 | Horizon XvuDQK · Special | 06/20/2008SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
| K071348 | Ems-Xl Cardiac Electrophysiology SystemDQK · Traditional | 09/07/2007SE |
| K070254 | Horizon SeDQK · Traditional | 04/19/2007SE |
Questions and answers
When was Bis Module for Envoy Patient Monitor cleared by the FDA?
Bis Module for Envoy Patient Monitor (K071899) received a 510(k) decision of Substantially Equivalent on October 22, 2007, 105 days after the submission was received.
What is the product code of K071899?
The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.