Eresearchtechnology GmbH 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
SpiroSphere, SpiroSphereECG, CardioSphere510(k)May 28, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 28, 2024
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU510(k)Jan 28, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 28, 2021