FDA 510(k) Application Details - K181623

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K181623
Device Name	Oximeter, Tissue Saturation
Applicant	Modulated Imaging, Inc. 17151 Gillette Ave Irvine, CA 92604 US Other 510(k) Applications for this Company
Contact	David Cuccia 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	06/20/2018
Decision Date	07/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review