Eko FAQ February 27, 2023 21:45 Updated Here's a list of common questions about our products. We hope this helps you when deciding to purchase our products. If you have more questions, contact support or chat with us at the bottom of the page. What clearances do Eko products have? Are Eko products HIPAA compliant? Can Eko products be used for telemedicine, virtual, or home care? What clearances do Eko products have? Clearance Eko products Location FDA CORE DUO Eko Analysis Software United States CE CORE DUO European Union Health Canada CORE DUO Canada TGA (Australia) CORE DUO Australia MDSAP Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP). N/A ISO 13485:2016 Eko maintains an ISO 13485 certified Quality Manufacturing System. N/A Brazilian Health Regulatory Agency ANVISA CORE Brazil See our regulatory information. Are Eko products HIPAA compliant? Yes, all Eko devices and software are HIPAA-compliant Can Eko products be used for telemedicine, virtual, or home care? Eko stethoscopes and software are purpose-built for telemedicine. Eko supports virtual care or telehealth programs for individual providers, small clinics, and multi-site hospitals. A subscription may be required for telemedicine live streaming. Speak with a telemedicine consultant.
