FDA 510(k) Application Details - K052465

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K052465
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	HEARTSINE TECHNOLOGIES, INC. 105 TERRY DR NEWTOWN, PA 18940 US Other 510(k) Applications for this Company
Contact	GEORGE BRDLIK 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	09/08/2005
Decision Date	12/12/2006
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