FDA 510(k) Application Details - K082861

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K082861
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT ELIZABETH, CO 80107 US Other 510(k) Applications for this Company
Contact	ALEXANDER B HENDERSON SR. 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	09/29/2008
Decision Date	11/25/2008
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