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

    ISOLETTE INFANT INCUBATOR, MODEL C2000E

    K Number: K031387 · Decision Aug 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    4
    Review Days
    91

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    Basic Information

    Device Name
    ISOLETTE INFANT INCUBATOR, MODEL C2000E
    K Number
    K031387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom Manufacturing, Inc.
    Date Received
    May 2, 2003
    Decision Date
    August 1, 2003
    Product Code
    FMZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMZ Incubator, Neonatal

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    Other Clearances by Hill-Rom Manufacturing, Inc.

    K Number Device Name
    K080226 NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
    K032772 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
    K014094 MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM