LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213100
    Device Name
    FMT Reusable Temperature Probes
    Manufacturer
    Metko Medikal ve Ttbbi Cihazlar D1s Ticaret Ltd. Sti
    Date Cleared
    2023-07-18

    (662 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FMT Reusable Temperature Probes

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FMT Reusable Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Biolight, GE, HP/Philips, Mindray, MTRE, S& W, Siemens/Drager, Tecotherm.

    These devices are used by qualified medical professional only.

    Device Description

    FMT Reusable Temperature Probes

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "FMT Reusable Temperature Probes." It acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance.

    However, there is no information within the provided text regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about AI/ML algorithm validation.

    This document is a regulatory approval, not a technical report detailing the performance evaluation of the device. Therefore, I cannot extract the requested information from the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1