BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CorSens

    K Number: K160656 · Decision Nov 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    258

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    Basic Information

    Device Name
    CorSens
    K Number
    K160656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2320
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corsens Medical , Ltd.
    Date Received
    March 8, 2016
    Decision Date
    November 21, 2016
    Product Code
    DXR
    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
    DXR Ballistocardiograph

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