Device Dossier

Information system, patient record

Device Dossier for Information system, patient record (Information system, patient record, Class IIb, sponsor LivaNova). ARTG record, intended purpose,…

Intended purpose

The Essenz Patient Monitor is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.

TGA Public Summary