Device Dossier
Eko CORE - Stethoscope, electronic
Device Dossier for Eko CORE - Stethoscope, electronic (Stethoscope, electronic, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category…
- GMDN category: Stethoscope, electronic
Intended purpose
The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on paediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.