FDA 510(k) Application Details - K130454

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K130454
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 REDMOND, WA 98073-9706 US Other 510(k) Applications for this Company
Contact	MICHELLE ACKERMANN 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	02/22/2013
Decision Date	08/21/2013
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