FDA.reportPublic FDA data

510(k) K131919

Device
ZOLL EPCR IOS
Applicant
ZOLL MEDICAL CORPORATION
510(k) number
K131919
Product code
DXJ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-12-17
Date received
2013-06-26
Regulation
870.2450
Classification name
Display, Cathode-ray Tube, Medical
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHANNON DUHAMEL
Address
269 Mill Rd. Chelsmford MA US 01824 01824

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases