inforMED
LELClass II

Device, Sleep Assessment

Neurology · 21 CFR 882.5050

MDR events13All time
Recalls0All time
Registered firms22Currently listed
510(k) clearances19All time

Recent MDR events

13 adverse event reports on file

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Event type breakdown

Malfunction7
Injury5
Unspecified1

Most-reported manufacturers

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Actigraph L.l.c.2Devilbiss Healthcare Llc2Health Dyne (somnitec)2Actigraph, Llc1Actigraph, Llc.1Compumedics1Compumedics Limited1Devilbiss Healthcare, Llc1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

22 firms currently registered for this product code

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510(k) clearances

19 clearances for this product code

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