FDA 510(k) Application Details - K071995

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K071995
Device Name	Detector And Alarm, Arrhythmia
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. P.O. BOX 527 REHOVOT 76101 IL Other 510(k) Applications for this Company
Contact	ALEX GONOROVSKY Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2007
Decision Date	12/18/2007
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