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

    INFANT LIFE SUPPORT MODULE-20

    K Number: K854065 · Decision Jan 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    104

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    Basic Information

    Device Name
    INFANT LIFE SUPPORT MODULE-20
    K Number
    K854065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Intl. Biomedics, Inc.
    Date Received
    October 4, 1985
    Decision Date
    January 16, 1986
    Product Code
    FPL
    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
    FPL Incubator, Neonatal Transport

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    Other Clearances by Intl. Biomedics, Inc.

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