FLA — Monitor, Temperature, Dialysis Class II

FDA Device Classification

Classification Details

Product Code
FLA
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140623nxstage medicalNXSTAGE EXPRESS FLUID WARMERJune 16, 2014
K842302organon teknikaFLUID WARMERAugust 27, 1984
K810021laminar flow industriesFLO-TEMPJanuary 23, 1981