Accurkardia, 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
AccurECG Analysis System (v2.0)510(k)Dec 22, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 22, 2025
AccurECG Analysis System510(k)Jun 23, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 23, 2023