FDA 510(k) Application Details - K020984

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K020984
Device Name	Automated External Defibrillators (Non-Wearable)
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	870.5310   More FDA Info for this Regulation Number
Classification Product Code	MKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2002
Decision Date	08/14/2002
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review