FDA Product Code
FDA Product Code OLW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260907 | BIS Advance pEEG Module | Covidien LP | 2026-08-13 | Traditional | PDF ↗ |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026-07-10 | Traditional | PDF ↗ |
| K230693 | BIS Advance Monitoring System | Covidien, LLC | 2024-02-26 | Traditional | PDF ↗ |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | 2023-09-01 | Traditional | PDF ↗ |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022-02-25 | Traditional | PDF ↗ |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | 2021-08-05 | Traditional | PDF ↗ |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018-01-26 | Traditional | PDF ↗ |
| K150298 | Entropy Module, E-ENTROPY-01 | Ge Healthcare Filand OY | 2015-11-12 | Traditional | PDF ↗ |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | 2008-12-16 | Traditional | PDF ↗ |
| K061907 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | 2008-03-27 | Traditional | PDF ↗ |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | 2007-11-20 | Traditional | PDF ↗ |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2007-10-22 | Traditional | PDF ↗ |
| K062613 | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | 2007-06-18 | Special | PDF ↗ |
| K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | Spacelabs Medical, Inc. | 2006-06-23 | Traditional | PDF ↗ |
| K060997 | SNAP II EEG MONITOR | Everest Biomedical Instruments Co. | 2006-06-15 | Traditional | PDF ↗ |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | 2005-11-01 | Special | PDF ↗ |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | 2005-09-09 | Special | PDF ↗ |
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | Physiometrix, Inc. | 2005-09-02 | Special | PDF ↗ |
| K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | GE Healthcare | 2005-08-23 | Special | PDF ↗ |
| K050835 | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | 2005-05-06 | Special | PDF ↗ |
| K042315 | CEREBRAL STATE MONITOR - CSM | Danmeter A/S | 2005-01-21 | Traditional | PDF ↗ |
| K033543 | NARCOTREND, MODEL COMPACT 4.0 | Mt Monitortechnik GmbH & Co. KG | 2004-09-17 | Traditional | PDF ↗ |
| K040183 | BISX | Aspect Medical Systems, Inc. | 2004-02-25 | Special | PDF ↗ |
| K033999 | SEDLINE WITH FRONTAL PSI | Physiometrix, Inc. | 2004-02-06 | Special | PDF ↗ |
| K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2004-01-15 | Traditional | PDF ↗ |
| K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K023459 | DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES | Datex-Ohmeda | 2003-01-13 | Traditional | PDF ↗ |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | Physiometrix, Inc. | 2002-10-04 | Special | PDF ↗ |
| K020218 | SNAP EEG MONITOR | Nicolet Biomedical, Inc. | 2002-04-22 | Abbreviated | PDF ↗ |
| K013389 | DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES | Datex-Ohmeda | 2002-01-10 | Traditional | PDF ↗ |
| K012466 | BIS/EEG MODULE | General Electric Medical Systems Information Techn | 2001-10-01 | Traditional | PDF ↗ |
| K011834 | BIS ENGINE | Aspect Medical Systems, Inc. | 2001-07-10 | Special | PDF ↗ |
| K010965 | A-LINE AEP MONITOR | Alaris Medical Systems, Inc. | 2001-06-27 | Traditional | PDF ↗ |
| K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | Aspect Medical Systems, Inc. | 2001-06-15 | Special | PDF ↗ |
| 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 | 2000-12-15 | Traditional | PDF ↗ |
| K002837 | BIS ENGINE | Aspect Medical Systems, Inc. | 2000-09-19 | Special | PDF ↗ |
| K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | Physiometrix, Inc. | 2000-06-30 | Traditional | PDF ↗ |
| K974496 | A-2000 EEG MONITOR WITH BIS | Aspect Medical Systems, Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K973596 | SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE | Spacelabs Medical, Inc. | 1998-02-03 | Traditional | PDF ↗ |
| K963644 | A-1000 EEG MONITOR AND A-1050 EEG MONITOR | Aspect Medical Systems, Inc. | 1996-10-08 | Traditional | PDF ↗ |
Product code OLW · Class II · Neurology. Data: openFDA.