BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

    K Number: K033040 · Decision Dec 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
    K Number
    K033040
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Hospital Supply Co.
    Date Received
    September 29, 2003
    Decision Date
    December 17, 2003
    Product Code
    FMT
    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
    FMT Warmer, Infant Radiant

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