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510(k) Data Aggregation

    K Number
    K061902
    Device Name
    COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
    Manufacturer
    INDITHERM MEDICAL
    Date Cleared
    2006-12-08

    (156 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDITHERM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.
    Device Description
    The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
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    K Number
    K051419
    Device Name
    INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1
    Manufacturer
    INDITHERM MEDICAL
    Date Cleared
    2006-04-27

    (330 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDITHERM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department; the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. In addition to providing warming and control, the mattress also provides pressure relief to help prevent pressure sores.
    Device Description
    The Inditherm Patient Warming System consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
    Ask a Question

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