FDA 510(k) Application Details - K190182

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K190182
Device Name	Pump, Infusion
Applicant	DEKA Research & Development 340 Commercial Street Manchester, NH 03101 US Other 510(k) Applications for this Company
Contact	Brian Carney Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2019
Decision Date	05/06/2019
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