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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
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (FMT Disposable and Autoclavable Temperature Probes). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the following information that you requested:

    • A table of acceptance criteria and reported device performance.
    • Details about a study proving the device meets acceptance criteria.
    • Sample size for the test set or data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication method for the test set.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
    • Information about a standalone (algorithm only) performance study.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document focuses on regulatory clearance based on substantial equivalence, not on the detailed results of performance studies that would include the information you've asked for. Such details would typically be found in a separate performance study report submitted as part of the 510(k) application, but they are not included in this FDA clearance letter.

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