FDA 510(k) Application Details - K100875

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K100875
Device Name	Oximeter, Tissue Saturation
Applicant	OR-NIM MEDICAL LTD. 1 YODFAT ST LOD 71291 IL Other 510(k) Applications for this Company
Contact	MICHAL BALBERG 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	03/30/2010
Decision Date	01/25/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review