FDA 510(k) Application Details - K062099

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K062099
Device Name	Tester, Defibrillator
Applicant	DATREND SYSTEMS, INC. 3531 JACOMBS RD., UNIT 1 RICHMOND, BRITISH COLUMBIA V6V 1Z8 CA Other 510(k) Applications for this Company
Contact	RON EVANS Other 510(k) Applications for this Contact
Regulation Number	870.5325   More FDA Info for this Regulation Number
Classification Product Code	DRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2006
Decision Date	01/25/2007
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