Regulatory March 22, 2023 19:18 Updated Our products are designed with quality as a top priority. They are evaluated to the highest regulatory standards. MDSAP Certified Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP). ISO 13485:2016 Certified Eko maintains an ISO 13485 certified Quality Manufacturing System. FDA Cleared Eko CORE, Eko DUO, and Eko Analysis Software are cleared by the FDA for sale in the United States. Eko CORE FDA Clearance Statement K200776 Eko DUO FDA Clearance Statement K170874 Eko CORE/DUO Analysis Software FDA Clearance Statement K192004 Eko Murmur Analysis Software (EMAS) FDA Clearance Statement K213794 CE Marked Eko CORE and DUO are CE Marked for sale within the European Union. Health Canada Approved Eko CORE and DUO are Health Canada approved for sale in Canada. TGA (Australia) Approved Eko CORE and DUO are TGA approved for sale in Australia. Brazilian Health Regulatory Agency (ANVISA) Approved Eko CORE is ANVISA approved for sale in Brazil. Eko Devices’ Financial Conflict of Interest (FCOI) Policy for NIH-Funded Research Eko Devices is dedicated to maintaining public trust in the integrity of our research-related activities. The management of financial conflicts of interest (FCOI) is crucial for safeguarding research objectivity and for compliance with federal regulations. Eko Devices seeks to ensure the integrity of its research and to comply with the Public Health Service (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (42 CFR 50, “FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants will be free from bias resulting from investigator FCOIs. This policy includes any research performed at Eko that is funded from NIH monies (PHS grants). Eko may be the primary research institution. Eko may be a sub-investigating/contracted research institution. This policy includes any investigators that are participating in NIH-funded research at Eko or any subcontracting organization. The policy provides mandatory training, policy documentation and essential details on processes that investigators must follow to comply with FOCI Regulations. Read full policy Manufacturer Address Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612
