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

    NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912

    K Number: K080226 · Decision Apr 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
    K Number
    K080226
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hill-Rom Manufacturing, Inc.
    Date Received
    January 29, 2008
    Decision Date
    April 9, 2008
    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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    Other Clearances by Hill-Rom Manufacturing, Inc.

    K Number Device Name
    K032772 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
    K031387 ISOLETTE INFANT INCUBATOR, MODEL C2000E
    K014094 MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM