Device Dossier

Single-patient physiologic monitoring system

Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Cubro). ARTG record,…

Intended purpose

The vital signs monitor is intended to be used by trained healthcare professionals to non-invasively measure, display, record, and store a patient’s basic physiological parameters, which may include non-invasive blood pressure (NIBP), oxygen saturation (SpO₂), pulse rate, and body temperature. The device provides spot-check or short-term monitoring of vital signs to assist clinicians in the assessment of a patient’s physiological status.

TGA Public Summary