FDA 510(k) Application Details - K241393

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K241393
Device Name	Oximeter, Tissue Saturation
Applicant	ODI Medical AS Karenslyst AllΘ 8A Oslo 0278 NO Other 510(k) Applications for this Company
Contact	Wenche Groennvold Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	MUD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2024
Decision Date	08/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review