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encevis

AIT Austrian Institute of Technology GmbH · Model 1.12 · UDI-DI 09120109830122

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

Description

encevis is a quantitative EEG trending, spike and seizure 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.