OMBClass II

Automatic Event Detection Software For Full-montage Electroencephalograph

Neurology · 21 CFR 882.1400

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

MDR events36All time

Recalls1All time

Registered firms34Currently listed

510(k) clearances42All time

Recent MDR events

36 adverse event reports on file

Event type breakdown

Malfunction33

Unspecified1

Death1

Other1

Most-reported manufacturers

Natus Medical Incorporated22 Natus Medical Incorporated Dba Excel-tech Ltd.8 Ceribell, Inc.1 Natus1 Natus Medical Inc1 Natus Medical Incorporated Dba Excel-tech Ltd. (xl1 Natus Medical Incorportated1 Natus Medicla Inc. Dba Excle-tech Ltd (xltek)1

Recalls

1 recall events for this product code

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
TerminatedUnknown
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.
Z-0661-2022 · View FDA record ↗

Registered firms

34 firms currently registered for this product code

510(k) clearances

42 clearances for this product code