Atsens Co., Ltd. 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
AT-Patch (ATP-C130/ATP-C70)510(k)May 2, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 2, 2025
AT-Patch ECG Analysis System510(k)Oct 12, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022