BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIGITAL AVERAGING TONOMETER

    K Number: K945972 · Decision Aug 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    252

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    Basic Information

    Device Name
    DIGITAL AVERAGING TONOMETER
    K Number
    K945972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Opti-Med Electronics
    Date Received
    December 8, 1994
    Decision Date
    August 17, 1995
    Product Code
    HKX
    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
    HKX Tonometer, Ac-Powered

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