BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    SOZO

    K Number: K190529 · Decision Nov 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    266

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    Basic Information

    Device Name
    SOZO
    K Number
    K190529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ImpediMed Limited
    Date Received
    March 4, 2019
    Decision Date
    November 25, 2019
    Product Code
    QJB
    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
    QJB Adjunct Monitor, Protein Calorie Malnutrition

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QJB), ordered by most recent decision date.

    SOZO Pro

    FDA 510(k)
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    Other Clearances by ImpediMed Limited

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    K230531 SOZO Pro
    K203473 SOZO
    K193410 SOZO Body Fluid Analyzer
    K180126 SOZO
    K172507 SOZO
    K172122 SOZO
    K130338 IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
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