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Index-Generating Electroencephalograph Software
FDA product code OLW · Class 2 · Neurology
118
Registered devices
330
Adverse events
1
Recalls
40
510(k) clearances
Devices with this code
BIS — Covidien LPCARESCAPE B850 — GE Healthcare Finland OyBIS — Covidien LPBIS — Covidien LPBIS — Covidien LPBIS — Covidien LPBIS — Covidien LPSmart Pressure Controller — Edwards Lifesciences LLCBIS — Covidien LPNA — GE Medical Systems Information Technologies, Inc.BIS — Covidien LPNA — GE Healthcare Finland OyBIS — Covidien LPNA — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.NeuroSENSE — Neurowave Systems Inc.CARESCAPE B650 — GE Healthcare Finland OyBIS — Covidien LPBIS — Covidien LPCARESCAPE Software — GE Healthcare Finland OyBIS — Covidien LPEEG Module w/ Cable — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.BIS — Covidien LPNA — GE Healthcare Finland OyBIS — Covidien LP
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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