FDA 510(k) Application Details - K100523

Device Classification Name	Oximeter, Tissue Saturation, Reprocessed   More FDA Info for this Device
510(K) Number	K100523
Device Name	Oximeter, Tissue Saturation, Reprocessed
Applicant	HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. BIRMINGHAM, AL 35211 US Other 510(k) Applications for this Company
Contact	LAKE TRECHSEL Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	NMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2010
Decision Date	05/04/2010
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