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    K Number
    K072621
    Device Name
    ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC
    Date Cleared
    2007-12-13

    (87 days)

    Product Code
    BZT
    Regulation Number
    868.1920
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K864043,K864044
    Why did this record match?
    Device Name :

    ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR

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

    Esophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B: The CSZ sesphageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or medal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.

    Boohageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24: The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal caperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.

    Device Description

    Disposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor s processed and displayed by the monitoring unit.

    AI/ML Overview

    The provided text describes a 510(k) submission for Esophageal/Rectal Temperature Probes and Esophageal Stethoscopes with Temperature Sensors. This submission focuses on demonstrating substantial equivalence to predicate devices and does not detail an AI device or a study involving acceptance criteria for AI performance. Therefore, I cannot generate the requested information based on the provided text.

    The document discusses:

    • Device Name: Esophageal/Rectal Temperature Probe, and Esophageal Stethoscope With Temperature Sensor Probe
    • Manufacturer: Cincinnati Sub-Zero Products, Inc. (CSZ)
    • Intended Use: Continuous measurement of core body temperature through the esophagus or the rectum.
    • Comparison to Predicate Devices: Smiths Level 1 Esophageal/Rectal Temperature Probe and Esophageal Stethoscope With Temperature Sensor Probe.
    • Non-clinical Tests: Testing was done in accordance with BS EN 12470-4, Clinical Thermometers.
    • Conclusion: The CSZ products meet the requirements of EN 12470-4 for Clinical Electronic Thermometers, and are therefore considered as safe and effective as the predicate device.

    None of this information pertains to an AI device, its acceptance criteria, or related studies.

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