FDA 510(k) Application Details - K083662

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K083662
Device Name	System, Thermal Regulating
Applicant	MTRE ADVANCED TECHNOLOGY LTD. 4 HA-YARDEN ST. (P.O.BOX 102 REHOVOT 76100) YAVNE 81228 IL Other 510(k) Applications for this Company
Contact	IFAT OREN Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2008
Decision Date	03/26/2009
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