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510(k) K873122

Device
TKS 4000 AUTO PERIMETER
Applicant
VISMED, INC.
510(k) number
K873122
Product code
HPT  
Decision
Substantially Equivalent (SESE)
Decision date
1987-11-02
Date received
1987-08-10
Regulation
886.1605
Classification name
Perimeter, Automatic, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DALE A RORABAUGH
Address
7920 Silverton Suite I San Diego CA US 92126 92126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092187MAIA, MODEL 1Centervue S.P.A.2010-05-27
K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.2010-03-12
K091579FORESEE HOMENotal Vision , Ltd.2009-12-23
K063310TRUEFIELD ANALYZERSeeing Machines Limited2007-08-02
K050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.2005-04-29
K023623NOVAVISION, MODEL 2.0Novavision, Inc.2003-04-22
K971156KASHA VISUAL FIELD SYSTEMKasha Software, Inc.1997-05-28
K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125Kowa Optimed, Inc.1996-06-17
K954167HUMPHREY FIELD ANALYZER (HFA II)Carl Zeiss, Inc.1995-11-24
K954037FIELD TRENDSynemed, Inc.1995-11-17
K943234MS-30 AUTOMATIC PERIMETERMarco Ophthalmic, Inc.1994-07-27
K932258OPTICOM M600Clement Clarke, Inc.1994-07-25
K930937LD 400Vismed, Inc.1993-10-18
K922294PERIKON PCL 90Optikon Oftalmologia Spa1993-01-28
K902878MT-336 AUTOMATIC PERIMETERMarco Technologies1990-09-18

Legacy Summary#

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FDA Review#

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