BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

    K Number: K240706 · Decision Dec 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
    K Number
    K240706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1760
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ganshorn Medizin Electronic GmbH
    Date Received
    March 14, 2024
    Decision Date
    December 9, 2024
    Product Code
    JEH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEH Plethysmograph, Volume

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