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510(k) Data Aggregation

    K Number
    K071977
    Device Name
    TARRY MEDICAL TEMPERATURE PROBES
    Date Cleared
    2008-05-23

    (311 days)

    Product Code
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TARRY MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.
    Device Description
    The Tarry Medical Temperature Probes are intended to be used as replacement parts as various neonatal incubators including: - Drager / Air Shields / Hill-Rom Isolette Incubators - Drager / Air Shields / Hill-Rom Incubators - GE / Ohmeda / Ohio IC and GC Care Plus - GE / Ohmeda Panda Baby Warmers - GE / Ohmeda Infant Warmer Systems This 510(k) includes the following probes: T-100 (skin temperature probe) T-3000 (skin temperature probe) T-20970 (skin temperature probe) T-20980 (air temperature probe) The temperature probes are for use with incubators and warmers in a hospital setting. The probes are reusable and reusable models. The probes were designed to meet OEM product specifications. The temperature probes include thermistors and are used with disposable probe covers.
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