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Index-Generating Electroencephalograph Software
FDA product code OLW · Class 2 · Neurology
121
Registered devices
361
Adverse events
1
Recalls
40
510(k) clearances
Devices with this code
NA — GE Medical Systems Information Technologies, Inc.CARESCAPE B450 — GE Healthcare Finland OyBIS — Covidien LPNA — GE Healthcare Finland OyBIS — Covidien LPHemoSphere Vita — Edwards Lifesciences LLCBIS — Covidien LPNA — GE Medical Systems Information Technologies, Inc.BIS — Covidien LPCARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.Narcotrend Patient lead — MT MonitorTechnik GmbH & Co. KGCARESCAPE — GE Healthcare Finland OyBIS — Covidien LPBIS — Covidien LPBIS — Covidien LPHemoSphere — Edwards Lifesciences LLCCOMEN — Shenzhen Comen Medical Instruments Co., Ltd.CARESCAPE B650 — GE Healthcare Finland OyCARESCAPE — GE Healthcare Finland OyBIS — Covidien LPNarcotrend-Compact M — MT MonitorTechnik GmbH & Co. KGBIS — Covidien LPCARESCAPE — GE Healthcare Finland OyNarcotrend Patient lead — MT MonitorTechnik GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-26 | Covidien LLC | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems |
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