DXJ — Display, Cathode-Ray Tube, Medical Class II

FDA Device Classification

Classification Details

Product Code
DXJ
Device Class
Class II
Regulation Number
870.2450
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212003livanova deutschlandESSENZ Patient MonitorNovember 10, 2021
K212208philips medizin systeme boeblingenPhilips IntelliVue GuardianSoftware (Rev. E.0X)September 30, 2021
K201162shenyang torch-bigtide digital technology coEssence 55SP Large Monitor SystemAugust 27, 2020
K173107vios medicalVios Central Station Monitor Software, Vios Central Server SoftwareJuly 26, 2018
K180534philips medizin systeme boeblingenPhilips IntelliVue GuardianSoftwareJuly 16, 2018
K173381barco n.vNexxis ORFebruary 22, 2018
K172969shenyang torch-bigtide digital technology coEssence 55S Large Monitor SystemJanuary 26, 2018
K170460sorin group deutschlandSorin ConnectJune 8, 2017
K170537barco n.vNexxis OR, NexxisApril 21, 2017
K161880barco n.vNIVR58-T kitMarch 14, 2017
K161767philips medizin systeme boeblingenPhilips IntelliVue GuardianSoftwareJanuary 27, 2017
K162012ge healthcareCARESCAPE Central Station V2September 15, 2016
K151366philips medical systemsPhilips CS770 IntelliSpace Critical Care and AnesthesiaOctober 30, 2015
K151736philips medizin systeme boblingenPhilips IntelliVue GuardianSoftwareOctober 21, 2015
K133994barco n.vSIVR56-T KITDecember 1, 2014
K133882ge medical systems information technologiesCARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)April 30, 2014
K132488zoll medical corporationZOLL CODE WRITERApril 3, 2014
K131272medusa medical technologiesSIREN EPCR SUITEJanuary 3, 2014
K131919zoll medical corporationZOLL EPCR IOSDecember 17, 2013
K131816sorin group deutschlandSORIN CONNECT DATA MANAGEMENT SYSTEMJuly 23, 2013