FDA 510(k) Application Details - K101703

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K101703
Device Name	Detector And Alarm, Arrhythmia
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 LAKEWOOD, CO 80228 US Other 510(k) Applications for this Company
Contact	CLAY ANESELMO 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	06/17/2010
Decision Date	07/13/2010
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