FDA 510(k) Application Details - K011461

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K011461
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	ACCESS CARDIOSYSTEMS, INC. 150 BAKER AVENUE EXTENSION SUITE 108 CONCORD, MA 01742 US Other 510(k) Applications for this Company
Contact	DAVID BARASH Other 510(k) Applications for this Contact
Regulation Number	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2001
Decision Date	05/28/2002
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