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510(k) K982612

Device
ESP7 VENOUS IMAGE
Applicant
IRONMASTER, INC.
510(k) number
K982612
Product code
KZA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-14
Date received
1998-07-27
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
FRED DAWSON
Address
1719 Grant St. Santa Clara CA US 95050 95050

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
K042679IR VIEWERInfrared Imaging Systems, Inc.2004-12-10
K780883E-Z-JECTORHarco Products1978-08-10
K780884HYPO-GRIPHarco Products1978-08-10

Legacy Summary#

summary

FDA Review#

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