FDA 510(k) Application Details - K040684

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K040684
Device Name	Oximeter, Tissue Saturation
Applicant	SPECTROS CORPORATION 4370 ALPINE ROAD SUITE 108 PORTOLA VALLEY, CA 94028 US Other 510(k) Applications for this Company
Contact	DAVID A BENARON 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	03/16/2004
Decision Date	11/05/2004
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