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510(k) K111905

Device
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
510(k) number
K111905
Product code
DXJ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-10-04
Date received
2011-07-05
Regulation
870.2450
Classification name
Display, Cathode-ray Tube, Medical
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARKUS STACHA
Address
Hewlett-Packard St. 2 Boeblingen, Baden-Wuerttemberg DE D 71034 D 71034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH2021-11-10
K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH2021-09-30
K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.2020-08-27
K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.2018-07-26
K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2018-07-16
K173381Nexxis ORBarco N.V.2018-02-22
K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.2018-01-26
K170460Sorin ConnectSorin Group Deutschland GmbH2017-06-08
K170537Nexxis OR, NexxisBarco N.V.2017-04-21
K161880NIVR58-T kitBarco N.V.2017-03-14
K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017-01-27
K162012CARESCAPE Central Station V2GE Healthcare2016-09-15
K151366Philips CS770 IntelliSpace Critical Care and AnesthesiaPhilips Medical Systems2015-10-30
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015-10-21
K133994SIVR56-T KITBarco N.V.2014-12-01

Legacy Summary#

summary

FDA Review#

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