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

    ALGESIOMETER

    K Number: K801907 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    36

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    Basic Information

    Device Name
    ALGESIOMETER
    K Number
    K801907
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1500
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Rowan Products, Inc.
    Date Received
    August 11, 1980
    Decision Date
    September 16, 1980
    Product Code
    GXB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXB Esthesiometer

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