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510(k) Data Aggregation

    K Number
    K131020
    Device Name
    TEMPERATURE SENSOR CATHETER
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2013-05-09

    (27 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPERATURE SENSOR CATHETER

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

    SILICONE FOLEY CATHETER WITH TS, 6FR, intended for urological use only. TSC indicated for drainage of the urinary bladder and simultaneous monitoring of temperature.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification FDA approval letter for a SILICONE FOLEY CATHETER WITH TS, 6FR, (TSC). It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.

    Therefore, I cannot provide the requested information from the provided text.

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