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510(k) Data Aggregation

    K Number
    K240223
    Device Name
    FMT Disposable and Autoclavable Temperature Probes
    Manufacturer
    Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi
    Date Cleared
    2024-10-25

    (273 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements. FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use. FMT Disposable and Autoclavable Temperature Probes are intended by qualified medical professionals only.
    Device Description
    FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements. FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.
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