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

    SOZO

    K Number: K172507 · Decision Dec 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    110
    Applicant Total
    9
    Review Days
    126

    Basic Information

    Device Name
    SOZO
    K Number
    K172507
    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
    August 18, 2017
    Decision Date
    December 22, 2017
    Product Code
    DSB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSB Plethysmograph, Impedance

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    Other Clearances by ImpediMed Limited

    K Number Device Name
    K232089 SOZO Pro
    K230531 SOZO Pro
    K230530 SOZO Pro
    K203473 SOZO
    K193410 SOZO Body Fluid Analyzer
    K190529 SOZO
    K180126 SOZO
    K172122 SOZO