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

    PregSense

    K Number: K191401 · Decision Mar 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    308

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    Basic Information

    Device Name
    PregSense
    K Number
    K191401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuvo- Group , Ltd.
    Date Received
    May 24, 2019
    Decision Date
    March 27, 2020
    Product Code
    LQK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQK Home Uterine Activity Monitor

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