FDA 510(k) Application Details - K153210

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K153210
Device Name	Tester, Defibrillator
Applicant	BC GROUP INTERNATIONAL, INC 3081 ELM POINT INDUSTRIAL DRIVE SAINT CHARLES, MO 63301 US Other 510(k) Applications for this Company
Contact	Mel Roche Other 510(k) Applications for this Contact
Regulation Number	870.5325   More FDA Info for this Regulation Number
Classification Product Code	DRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2015
Decision Date	12/21/2015
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