FDA 510(k) Application Details - K110192

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K110192
Device Name	Tester, Defibrillator
Applicant	BC GROUP INTERNATIONAL, INC 2913 209TH LANE NW OAK GROVE, MN 55011 US Other 510(k) Applications for this Company
Contact	JACK SLOVICK 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	01/24/2011
Decision Date	02/08/2011
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	Y
Expedited Review