BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    PUREtrace™

    K Number: K153262 · Decision Feb 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    455

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    Basic Information

    Device Name
    PUREtrace™
    K Number
    K153262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nemo Healthcare BV
    Date Received
    November 10, 2015
    Decision Date
    February 7, 2017
    Product Code
    OSP
    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
    OSP Uterine Electromyographic Monitor

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