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encevis

AIT Austrian Institute of Technology GmbH · Model 2.1/2.2 · UDI-DI 09120109830269

OMBOLTOMA Prescription
1
510(k) clearances
36
Adverse events (1 deaths)
1
Recalls
13
Facilities

Description

encevis is a quantitative EEG trending, spike, seizure and status epilepticus detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.

Recalls

DateFirmReason
2021-12-02Natus Neurology DBA Excel Tech., Ltd. (XLTEK)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 thi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.