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

    BLADE GAUGE

    K Number: K812011 · Decision Jul 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    162
    Registration Numbers
    162
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    11

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    Basic Information

    Device Name
    BLADE GAUGE
    K Number
    K812011
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Koi, Inc.
    Date Received
    July 17, 1981
    Decision Date
    July 28, 1981
    Product Code
    HOE
    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
    HOE Caliper, Ophthalmic

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