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510(k) K042679

Device
IR VIEWER
Applicant
Infrared Imaging Systems, Inc.
510(k) number
K042679
Product code
KZA
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-10
Date received
2004-09-29
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
N

Applicant Contact#

Contact
DALE SIEGEL
Address
1275 Kinnear Rd. Columbus OH US 43212 43212

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
K152088IV-eyeNovarix Limited2016-02-24
K101838VTS1000Vuetek Scientific, LLC2011-02-18
K982612ESP7 VENOUS IMAGEIronmaster, Inc.1998-12-14
K780883E-Z-JECTORHarco Products1978-08-10
K780884HYPO-GRIPHarco Products1978-08-10