Epitel, Inc. FDA Approvals

0 new drug approvals and 4 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
REMI-AI Rapid Detection Module (REMI-AI RDM)510(k)Oct 17, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 17, 2024
REMI AI Discrete Detection Module510(k)Jan 3, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 3, 2024
REMI Remote EEG Monitoring System510(k)Jun 30, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 30, 2023
REMI510(k)Mar 29, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 29, 2021