BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Mural Perinatal Surveillance

    K Number: K220732 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    31
    Review Days
    101

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    Basic Information

    Device Name
    Mural Perinatal Surveillance
    K Number
    K220732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies, Inc.
    Date Received
    March 14, 2022
    Decision Date
    June 23, 2022
    Product Code
    HGM
    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
    HGM System, Monitoring, Perinatal

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