FDA 510(k) Application Details - K072114

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K072114
Device Name	Tester, Defibrillator
Applicant	FLUKE BIOMEDICAL 1717 WEST COLLINS AVE. ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	COLLEEN BOSWELL 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	08/01/2007
Decision Date	01/28/2008
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