FDA 510(k) Application Details - DEN240038

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240038
Device Name	Oxiplex«
Applicant	FzioMed, Inc. 231 Bonetti Drive San Luis Obispo, CA 93401 US Other 510(k) Applications for this Company
Contact	Lisa Gawehn Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2024
Decision Date	06/17/2025
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review