FDA 510(k) Application Details - K061023

Device Classification Name	Hyperthermia Monitor   More FDA Info for this Device
510(K) Number	K061023
Device Name	Hyperthermia Monitor
Applicant	LIFE RECOVERY SYSTEMS HD, LLC 29 ANTHONY TERRACE DURHAM, CT 06422 US Other 510(k) Applications for this Company
Contact	PAUL A TENTHOREY Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	NZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2006
Decision Date	09/20/2006
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