Etiometry, Inc. FDA Approvals

0 new drug approvals and 5 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
Etiometry Platform510(k)Apr 3, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 3, 2026
Etiometry Platform (DAV 5.4 RAE 9.2)510(k)Feb 12, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
T3 Platform software510(k)Jul 7, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 7, 2023
T3 Platform software510(k)Jan 6, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 6, 2023
T3 Platform Software510(k)Jun 22, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 22, 2022