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

    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

    K Number: K010998 · Decision Jun 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
    K Number
    K010998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Langham Ophthalmic Technologies
    Date Received
    April 3, 2001
    Decision Date
    June 27, 2001
    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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