Beacon Biosignals, 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
Report Studio510(k)Aug 25, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2026
Dreem 3S510(k)Nov 22, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 22, 2024
SleepStageML510(k)Mar 8, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 8, 2024
Dreem 3S510(k)Aug 18, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 18, 2023