FDA 510(k) Application Details - K100739

Device Classification Name	Probe, Thermodilution   More FDA Info for this Device
510(K) Number	K100739
Device Name	Probe, Thermodilution
Applicant	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	PATRICIA MILBANK Other 510(k) Applications for this Contact
Regulation Number	870.1915   More FDA Info for this Regulation Number
Classification Product Code	KRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2010
Decision Date	12/07/2010
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