FDA 510(k) Application Details - DEN200038

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200038
Device Name	Gili Pro BioSensor (also known as ôGili BioSensor Systemö)
Applicant	ContinUse Biometrics Ltd. HaBarzel 32B Tel-Aviv 6971048 IL Other 510(k) Applications for this Company
Contact	Sagi Polani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2020
Decision Date	04/01/2021
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review