OLWClass II

Index-generating Electroencephalograph Software

Neurology · 21 CFR 882.1400

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

MDR events330All time

Recalls1All time

Registered firms83Currently listed

510(k) clearances39All time

Recent MDR events

330 adverse event reports on file

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Event type breakdown

Malfunction315

Injury14

Death1

Most-reported manufacturers

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Mmj Sa De Cv (usd)131 Covidien Llc77 Jabil Circuit Singapore Pte Ltd62 Philips Medizin Systeme Böblingen Gmbh22 Masimo - 15750 Alton Pkwy19 Aspect Medical5 Covidien Llc3 Celestica Electronics S Pte Ltd2

Recalls

1 recall events for this product code

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Covidien LLC
Open, ClassifiedUnknown
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Z-2958-2018 · View FDA record ↗

Registered firms

83 firms currently registered for this product code

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510(k) clearances

39 clearances for this product code

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