FDA 510(k) Application Details - K110499

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K110499
Device Name	Detector And Alarm, Arrhythmia
Applicant	CARD GUARD SCIENTIFIC SURVIVAL LTD. 555 ZANG ST SUITE 100 LAKEWOOD, CO 80228 US Other 510(k) Applications for this Company
Contact	CLAY ANSELMO 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	02/22/2011
Decision Date	04/06/2011
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