FDA 510(k) Application Details - DEN230020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230020
Device Name	BioTraceIO Lite
Applicant	TechsoMed Medical Technologies Ltd. Meir Weisgal 2 Rehovot 7654055 IL Other 510(k) Applications for this Company
Contact	Dalia Dickman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2023
Decision Date	12/22/2023
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review