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510(k) Data Aggregation

    K Number
    K013805
    Device Name
    KOWA AUTOMATED TONOMETER KT-500
    Manufacturer
    KOWA OPTIMED, INC.
    Date Cleared
    2002-10-11

    (330 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA OPTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.
    Device Description
    Not Found
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    K Number
    K961090
    Device Name
    AUTOMATIC VISUAL FIELD PLOTTER AP-125
    Manufacturer
    KOWA OPTIMED, INC.
    Date Cleared
    1996-06-17

    (90 days)

    Product Code
    HPT
    Regulation Number
    886.1605
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA OPTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960924
    Device Name
    KOWA HAND-HELD APPLANATION TONOMETER HA-1
    Manufacturer
    KOWA OPTIMED, INC.
    Date Cleared
    1996-06-04

    (90 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA OPTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955442
    Device Name
    KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
    Manufacturer
    KOWA OPTIMED, INC.
    Date Cleared
    1996-01-03

    (36 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA OPTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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