FDA 510(k) Application Details - K103651

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K103651
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L ROCKAWAY, NJ 07866 US Other 510(k) Applications for this Company
Contact	NICK MENDISE 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	12/14/2010
Decision Date	10/04/2011
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