Product code OLW
- Device name
- Index-Generating Electroencephalograph Software
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230693 | BIS™ Advance Monitoring System | Covidien, LLC | 2024-02-26 |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | 2023-09-01 |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022-02-25 |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | 2021-08-05 |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018-01-26 |
| K150298 | Entropy Module, E-ENTROPY-01 | Ge Healthcare Filand OY | 2015-11-12 |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | 2008-12-16 |
| K061907 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | 2008-03-27 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | 2007-11-20 |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2007-10-22 |
| K062613 | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | 2007-06-18 |
| K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | Spacelabs Medical, Inc. | 2006-06-23 |
| K060997 | SNAP II EEG MONITOR | Everest Biomedical Instruments Co. | 2006-06-15 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | 2005-11-01 |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | 2005-09-09 |
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | Physiometrix, Inc. | 2005-09-02 |
| K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | GE Healthcare | 2005-08-23 |
| K050835 | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | 2005-05-06 |
| K042315 | CEREBRAL STATE MONITOR - CSM | Danmeter A/S | 2005-01-21 |
| K033543 | NARCOTREND, MODEL COMPACT 4.0 | Mt Monitortechnik GmbH & Co. KG | 2004-09-17 |
| K040183 | BISX | Aspect Medical Systems, Inc. | 2004-02-25 |
| K033999 | SEDLINE WITH FRONTAL PSI | Physiometrix, Inc. | 2004-02-06 |
| K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2004-01-15 |
| K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2003-08-29 |
| K023459 | DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES | Datex-Ohmeda | 2003-01-13 |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | Physiometrix, Inc. | 2002-10-04 |
| K020218 | SNAP EEG MONITOR | Nicolet Biomedical, Inc. | 2002-04-22 |
| K013389 | DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES | Datex-Ohmeda | 2002-01-10 |
| K012466 | BIS/EEG MODULE | General Electric Medical Systems Information Techn | 2001-10-01 |
| K011834 | BIS ENGINE | Aspect Medical Systems, Inc. | 2001-07-10 |
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| 10841522108754 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-05-13 |
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| 10843997012802 | RD Sedline | MASIMO CORPORATION | 2023-08-22 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00690103202762 | HemoSphere | Edwards Lifesciences LLC | 2021-07-23 |
| 00690103199321 | HEMOSPHERE | Edwards Lifesciences LLC | 2019-01-04 |
| 90884521657515 | BIS | Covidien LP | 2018-08-03 |
| 00690103197006 | HemoSphere | Edwards Lifesciences LLC | 2017-07-24 |
| 20884521134505 | BIS | Covidien LP | 2016-10-20 |
| 10841522100253 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-10 |
| 00840682104425 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104432 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104449 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104456 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104463 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682103930 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-03 |
| 00840682103978 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682103992 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105118 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105200 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105224 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682104272 | NA | GE Healthcare Finland Oy | 2016-05-20 |