BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    INCU I

    K Number: K102279 · Decision Dec 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    81
    Applicant Total
    10
    Review Days
    140

    Basic Information

    Device Name
    INCU I
    K Number
    K102279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ATOM MEDICAL CORPORATION
    Date Received
    August 11, 2010
    Decision Date
    December 29, 2010
    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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    K102542 RESUSCI FLOW; RESUSCI FLOW 104
    K103828 BILI-THERAPY SPOT TYPE
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    K102710 NEO-SERVO I