inforMED
OMCClass II

Reduced- Montage Standard Electroencephalograph

Neurology · 21 CFR 882.1400

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

MDR events7All time
Recalls0All time
Registered firms139Currently listed
510(k) clearances29All time

Recent MDR events

7 adverse event reports on file

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Event type breakdown

Malfunction6
Injury1

Most-reported manufacturers

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Natus Medical Incorporated3Natus Medical Incorporated Dba Excel-tech Ltd.2Epitel, Inc.1Jabil Circuit Singapore Pte Ltd1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

139 firms currently registered for this product code

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510(k) clearances

29 clearances for this product code

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