FDA 510(k) Application Details - K153760

Device Classification Name	Controller, Infusion, Intravascular, Electronic   More FDA Info for this Device
510(K) Number	K153760
Device Name	Controller, Infusion, Intravascular, Electronic
Applicant	DEKA RESEARCH & DEVELOPMENT 340 COMMERCIAL ST. MANCHESTER, NH 03101 US Other 510(k) Applications for this Company
Contact	Julie Perkins Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2015
Decision Date	10/03/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review