FDA 510(k) Application Details - K111745

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K111745
Device Name	Recorder, Magnetic Tape, Medical
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET 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	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2011
Decision Date	08/01/2011
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