Our products are designed with quality as a top priority. They are evaluated to the highest regulatory standards.
Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP).
These Eko products are cleared by the FDA for sale in the United States:
Eko CORE 500™ Digital Stethoscope FDA Clearance Statement K230111
Eko CORE™ FDA Clearance Statement K200776
Eko DUO™ FDA Clearance Statement K170874
Eko Analysis Software FDA Clearance Statement K192004
Eko Murmur Analysis Software (EMAS) FDA Clearance Statement K213794
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).
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Eko may be the primary research institution.
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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.