inforMED
OLVClass II

Standard Polysomnograph With Electroencephalograph

Neurology · 21 CFR 882.1400

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

MDR events21All time
Recalls1All time
Registered firms118Currently listed
510(k) clearances64All time

Recent MDR events

21 adverse event reports on file

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Event type breakdown

Malfunction19
Injury2

Most-reported manufacturers

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Natus Medical Incorporated4Natus Medical Incorporated Dba Excel-tech Ltd.4Carefusion 207, Inc. Dba Carefusion3Respironics, Inc.3Vyaire Medical2Vyaire Medical, Inc2Carefusion, Inc1Natus Neurology Incorporated1

Recalls

1 recall events for this product code

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Registered firms

118 firms currently registered for this product code

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510(k) clearances

64 clearances for this product code

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