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510(k) K152088

Device
IV-eye
Applicant
Novarix Limited
510(k) number
K152088
Product code
KZA  
Decision
Substantially Equivalent (SESE)
Decision date
2016-02-24
Date received
2015-07-27
Regulation
880.6970
Classification name
Device, Vein Location, Liquid Crystal
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN SCOTT
Address
The Core Business Centre, Milton Hill Abingdon GB OX13 6AB OX13 6AB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KZA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101838VTS1000Vuetek Scientific, LLC2011-02-18
K042679IR VIEWERInfrared Imaging Systems, Inc.2004-12-10
K982612ESP7 VENOUS IMAGEIronmaster, Inc.1998-12-14
K780883E-Z-JECTORHarco Products1978-08-10
K780884HYPO-GRIPHarco Products1978-08-10

Legacy Summary#

summary

FDA Review#

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