Eko Devices, Inc. FDA Approvals

0 new drug approvals and 2 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 500 Digital Stethoscope510(k)May 26, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 26, 2023
Eko Murmur Analysis Software (EMAS)510(k)Jun 29, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022