Index-Generating Electroencephalograph Software
Regulation 882.1400
2510(k)s in 12 months (40 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLW
| Company | 510(k)s | Recalls |
|---|---|---|
| Aspect Medical Systems, Inc. | 12 | 0 |
| Physiometrix, Inc. | 4 | 0 |
| Covidien LP | 2 | 1 |
| GE Healthcare | 3 | 0 |
| Masimo Corporation | 3 | 0 |
| Datex-Ohmeda | 2 | 0 |
| Mennen Medical , Ltd. | 2 | 0 |
| Spacelabs Medical, Inc. | 2 | 0 |
| Agilent Technologies Deutschland GmbH | 1 | 0 |
| Alaris Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2026 | K260907 | BIS Advance pEEG Module Covidien LP | OLW |
| Jul 10, 2026 | K260880 | SedLine Sedation Monitor Masimo Corporation | OLW |
| Feb 26, 2024 | K230693 | BIS Advance Monitoring System Covidien, LLC | OLW |
| Sep 1, 2023 | K213273 | Brain Anesthesia Response Monitor (Bar Monitor) Cortical Dynamics , Ltd., AU | OLW |
| Feb 25, 2022 | K203113 | Masimo SedLine Sedation Monitor and Accessories Masimo Corporation | OLW |
| Aug 5, 2021 | K202621 | NeuroSENSE Monitoring System, Model NS-901 Neurowave Systems, Inc. | OLW |
| Jan 26, 2018 | K172890 | SedLine Sedation Monitor Masimo Corporation | OLW |
| Nov 12, 2015 | K150298 | Entropy Module, E-ENTROPY-01 Ge Healthcare Filand OY, FI | OLW |
| Dec 16, 2008 | K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS Mennen Medical , Ltd., IL | OLW |
| Mar 27, 2008 | K061907 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE Healthcare | OLW |
| Nov 20, 2007 | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX Aspect Medical Systems, Inc. | OLW |
| Oct 22, 2007 | K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | OLW |
| Jun 18, 2007 | K062613 | BIS EEG MONITOR VIEW Aspect Medical Systems, Inc. | OLW |
| Jun 23, 2006 | K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 Spacelabs Medical, Inc. | OLW |
| Jun 15, 2006 | K060997 | SNAP II EEG MONITOR Everest Biomedical Instruments Co. | OLW |
| Nov 1, 2005 | K052981 | BIS EEG MONITOR, MODEL BISX4 Aspect Medical Systems, Inc. | OLW |
| Sep 9, 2005 | K052362 | BIS EEG MONITOR, MODEL A-3000 Aspect Medical Systems, Inc. | OLW |
| Sep 2, 2005 | K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET Physiometrix, Inc. | OLW |
| Aug 23, 2005 | K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE Healthcare | OLW |
| May 6, 2005 | K050835 | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE Healthcare | OLW |
| Jan 21, 2005 | K042315 | CEREBRAL STATE MONITOR - CSM Danmeter A/S, DK | OLW |
| Sep 17, 2004 | K033543 | NARCOTREND, MODEL COMPACT 4.0 Mt Monitortechnik GmbH & Co. KG, DE | OLW |
| Feb 25, 2004 | K040183 | BISX Aspect Medical Systems, Inc. | OLW |
| Feb 6, 2004 | K033999 | SEDLINE WITH FRONTAL PSI Physiometrix, Inc. | OLW |
| Jan 15, 2004 | K030267 | EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. | OLW |
| Aug 29, 2003 | K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. | OLW |
| Jan 13, 2003 | K023459 | DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES Datex-Ohmeda | OLW |
| Oct 4, 2002 | K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI Physiometrix, Inc. | OLW |
| Apr 22, 2002 | K020218 | SNAP EEG MONITOR Nicolet Biomedical, Inc. | OLW |
| Jan 10, 2002 | K013389 | DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES Datex-Ohmeda | OLW |
| Oct 1, 2001 | K012466 | BIS/EEG MODULE General Electric Medical Systems Information Techn | OLW |
| Jul 10, 2001 | K011834 | BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Jun 27, 2001 | K010965 | A-LINE AEP MONITOR Alaris Medical Systems, Inc. | OLW |
| Jun 15, 2001 | K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Dec 15, 2000 | K003038 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A Agilent Technologies Deutschland GmbH, DE | OLW |
| Sep 19, 2000 | K002837 | BIS ENGINE Aspect Medical Systems, Inc. | OLW |
| Jun 30, 2000 | K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) Physiometrix, Inc. | OLW |
| Feb 6, 1998 | K974496 | A-2000 EEG MONITOR WITH BIS Aspect Medical Systems, Inc. | OLW |
| Feb 3, 1998 | K973596 | SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE Spacelabs Medical, Inc. | OLW |
| Oct 8, 1996 | K963644 | A-1000 EEG MONITOR AND A-1050 EEG MONITOR Aspect Medical Systems, Inc. | OLW |
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