BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VKG 2000 VIDEO KERATOMETER

    K Number: K893968 · Decision Sep 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    101

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    Basic Information

    Device Name
    VKG 2000 VIDEO KERATOMETER
    K Number
    K893968
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Technitex, Inc.
    Date Received
    June 2, 1989
    Decision Date
    September 11, 1989
    Product Code
    HJA
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJA Photokeratoscope

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    Other Clearances by Technitex, Inc.

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    K883471 VKG 1000, VIDEO KERATOMETER
    K882902 QRK 100, QUALITATIVE RING KERATOSCOPE