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

    ReDS System

    K Number: K180479 · Decision Feb 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    371

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    Basic Information

    Device Name
    ReDS System
    K Number
    K180479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sensible Medical Innovations , Ltd.
    Date Received
    February 22, 2018
    Decision Date
    February 28, 2019
    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 Sensible Medical Innovations , Ltd.

    K Number Device Name
    K150095 ReDs Wearable System