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

    VISTITOME 20-10 MICROKERATOME

    K Number: K014000 · Decision Mar 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    VISTITOME 20-10 MICROKERATOME
    K Number
    K014000
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biovision AG
    Date Received
    December 4, 2001
    Decision Date
    March 11, 2002
    Product Code
    HNO
    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
    HNO Keratome, Ac-Powered

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    Other Clearances by Biovision AG

    K Number Device Name
    K042083 MODIFICATION TO VISITOME 20-10 MICROKERATOME