FDA 510(k) Application Details - K192322

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K192322
Device Name	Oximeter, Tissue Saturation
Applicant	Spectros Corporation 274 E Hamilton Ave Suite H Campbell, CA 95008 US Other 510(k) Applications for this Company
Contact	Bill Curnan 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	08/27/2019
Decision Date	09/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review