FDA 510(k) Application Details - K122600

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K122600
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO 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	08/27/2012
Decision Date	10/11/2012
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