FDA 510(k) Application Details - K242171

Device Classification Name	More FDA Info for this Device
510(K) Number	K242171
Device Name	TechCare Trauma
Applicant	Milvue 29 Rue du Faubourg Saint Jacques Paris 75014 FR Other 510(k) Applications for this Company
Contact	Mathieu Quintin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2024
Decision Date	01/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review