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

    TCD OR TCD NEUROPATHY STAR

    K Number: K944234 · Decision Mar 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    189

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    Basic Information

    Device Name
    TCD OR TCD NEUROPATHY STAR
    K Number
    K944234
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jcm Management & Planning Co.
    Date Received
    August 31, 1994
    Decision Date
    March 8, 1995
    Product Code
    GWI
    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
    GWI Discriminator, Two-Point

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    AESTHESIOMETER

    FDA 510(k)
    FDA Class 1 ·Neurology
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