FDA 510(k) Application Details - K100915

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K100915
Device Name	Oximeter, Tissue Saturation
Applicant	HUTCHINSON TECHNOLOGY, INC. 40 WEST HIGHLAND PARK DR. NE HUTCHINSON, MN 55350 US Other 510(k) Applications for this Company
Contact	COLIN MCGRAW 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	04/01/2010
Decision Date	04/30/2010
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