| SedLine Sedation Monitor (K260880) | Masimo Corporation | 2026-07-10 |
| BIS™ Advance Monitoring System (K230693) | Covidien, LLC | 2024-02-26 |
| Brain Anesthesia Response Monitor (Bar Monitor) (K213273) | Cortical Dynamics , Ltd. | 2023-09-01 |
| Masimo SedLine Sedation Monitor and Accessories (K203113) | Masimo Corporation | 2022-02-25 |
| NeuroSENSE Monitoring System, Model NS-901 (K202621) | Neurowave Systems, Inc. | 2021-08-05 |
| SedLine Sedation Monitor (K172890) | Masimo Corporation | 2018-01-26 |
| Entropy Module, E-ENTROPY-01 (K150298) | Ge Healthcare Filand OY | 2015-11-12 |
| BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (K083063) | Mennen Medical , Ltd. | 2008-12-16 |
| MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K061907) | GE Healthcare | 2008-03-27 |
| BIS EEG VISTA MONITOR SYSTEM AND BISX (K072286) | Aspect Medical Systems, Inc. | 2007-11-20 |
| BIS MODULE FOR ENVOY PATIENT MONITOR (K071899) | Mennen Medical , Ltd. | 2007-10-22 |
| BIS EEG MONITOR VIEW (K062613) | Aspect Medical Systems, Inc. | 2007-06-18 |
| SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 (K060900) | Spacelabs Medical, Inc. | 2006-06-23 |
| SNAP II EEG MONITOR (K060997) | Everest Biomedical Instruments Co. | 2006-06-15 |
| BIS EEG MONITOR, MODEL BISX4 (K052981) | Aspect Medical Systems, Inc. | 2005-11-01 |
| BIS EEG MONITOR, MODEL A-3000 (K052362) | Aspect Medical Systems, Inc. | 2005-09-09 |
| SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET (K051874) | Physiometrix, Inc. | 2005-09-02 |
| DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES (K052145) | GE Healthcare | 2005-08-23 |
| DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K050835) | GE Healthcare | 2005-05-06 |
| CEREBRAL STATE MONITOR - CSM (K042315) | Danmeter A/S | 2005-01-21 |
| NARCOTREND, MODEL COMPACT 4.0 (K033543) | Mt Monitortechnik GmbH & Co. KG | 2004-09-17 |
| BISX (K040183) | Aspect Medical Systems, Inc. | 2004-02-25 |
| SEDLINE WITH FRONTAL PSI (K033999) | Physiometrix, Inc. | 2004-02-06 |
| EEG MONITOR WITH BIS, MODEL A-2000 (K030267) | Aspect Medical Systems, Inc. | 2004-01-15 |
| MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 (K031694) | Aspect Medical Systems, Inc. | 2003-08-29 |
| DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES (K023459) | Datex-Ohmeda | 2003-01-13 |
| PSA4000 EEG MONITOR WITH FRONTAL PSI (K020671) | Physiometrix, Inc. | 2002-10-04 |
| SNAP EEG MONITOR (K020218) | Nicolet Biomedical, Inc. | 2002-04-22 |
| DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES (K013389) | Datex-Ohmeda | 2002-01-10 |
| BIS/EEG MODULE (K012466) | General Electric Medical Systems Information Techn | 2001-10-01 |
| BIS ENGINE (K011834) | Aspect Medical Systems, Inc. | 2001-07-10 |
| A-LINE AEP MONITOR (K010965) | Alaris Medical Systems, Inc. | 2001-06-27 |
| EEG MIS MONITOR MODEL # A-2000; BIS ENGINE (K011534) | Aspect Medical Systems, Inc. | 2001-06-15 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A (K003038) | Agilent Technologies Deutschland GmbH | 2000-12-15 |
| BIS ENGINE (K002837) | Aspect Medical Systems, Inc. | 2000-09-19 |
| MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (K001069) | Physiometrix, Inc. | 2000-06-30 |
| A-2000 EEG MONITOR WITH BIS (K974496) | Aspect Medical Systems, Inc. | 1998-02-06 |
| SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE (K973596) | Spacelabs Medical, Inc. | 1998-02-03 |
| A-1000 EEG MONITOR AND A-1050 EEG MONITOR (K963644) | Aspect Medical Systems, Inc. | 1996-10-08 |