FDA 510(k) Application Details - K122758

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K122758
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	CARDIAC SCIENCE CORPORATION N7 W22025 Johnson Dr -- Waukesha, WI 53186 US Other 510(k) Applications for this Company
Contact	KATHLEEN ROBERTS 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	09/10/2012
Decision Date	02/12/2014
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