inforMED
OLTClass II

Non-normalizing Quantitative Electroencephalograph Software

Neurology · 21 CFR 882.1400

Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.

MDR events35All time
Recalls0All time
Registered firms175Currently listed
510(k) clearances55All time

Recent MDR events

35 adverse event reports on file

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Event type breakdown

Malfunction30
Death2
Injury2
Other1

Most-reported manufacturers

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Nihon Kohden Corporation32Natus Medical Incorporated1Natus Medical Incorporated Dba Excel-tech Ltd. (xltek)1Nihon Kohden Tomioka Corporation1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

175 firms currently registered for this product code

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510(k) clearances

55 clearances for this product code

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