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

    TREMOROMETER

    K Number: K010270 · Decision Jul 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    177

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    Basic Information

    Device Name
    TREMOROMETER
    K Number
    K010270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flexable Systems, Inc.
    Date Received
    January 29, 2001
    Decision Date
    July 25, 2001
    Product Code
    GYD
    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
    GYD Transducer, Tremor

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