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

    HL 188 & HL 189 BODY FAT METER

    K Number: K043414 · Decision Feb 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    60
    Review Days
    58

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    Basic Information

    Device Name
    HL 188 & HL 189 BODY FAT METER
    K Number
    K043414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health & Life Co., Ltd.
    Date Received
    December 13, 2004
    Decision Date
    February 9, 2005
    Product Code
    MNW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNW Analyzer, Body Composition

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