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

    Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM

    K Number: K992874 · Decision Nov 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
    K Number
    K992874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wr Medical Electronics Co.
    Date Received
    August 26, 1999
    Decision Date
    November 18, 1999
    Product Code
    KTB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTB Device, Iontophoresis, Specific Uses

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