FDA 510(k) Application Details - K140387

Device Classification Name	More FDA Info for this Device
510(K) Number	K140387
Device Name	Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
Applicant	THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE FORT DETRICK, MD 21702 US Other 510(k) Applications for this Company
Contact	KENNETH A BERTRAM, MD, PHD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2014
Decision Date	12/23/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review