FDA 510(k) Application Details - K970719

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K970719
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT. CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	TIM J WAY 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	02/27/1997
Decision Date	04/16/1997
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