Eko Health, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CORE 300 Digital Stethoscope510(k)Jul 23, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 23, 2026
Eko Foundation Analysis Software with Transformers (EFAST)510(k)Aug 12, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 12, 2025
CORE 500 Digital Stethoscope510(k)Mar 28, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)510(k)Mar 28, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 28, 2024