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510(k) K132488

Device
ZOLL CODE WRITER
Applicant
ZOLL MEDICAL CORPORATION
510(k) number
K132488
Product code
DXJ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-03
Date received
2013-08-08
Regulation
870.2450
Classification name
Display, Cathode-ray Tube, Medical
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
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#

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