FDA 510(k) Application Details - K150349

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K150349
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	FULL POWER AED 707 East Hudson Ave Durham, NC 27704 US Other 510(k) Applications for this Company
Contact	Jahn Power Other 510(k) Applications for this Contact
Regulation Number	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2015
Decision Date	07/14/2015
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