Bistos Co., Ltd. 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
Hi bebe super (BT-150B)510(k)Sep 25, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Sep 25, 2025
BT-1000510(k)Aug 28, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2024
Infant Phototherapy Equipment510(k)May 28, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 28, 2021
Hi bebe super (Models BT-150S and BT-150L)510(k)Feb 10, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Feb 10, 2021