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510(k) Data Aggregation

    K Number
    K982846
    Device Name
    MTEK-1400
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-09-18

    (37 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MTEK-1400

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

    The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "MTEK-1400". It does not contain information about acceptance criteria, study details, or performance data as requested. The letter confirms substantial equivalence to a predicate device but does not provide the supporting study data.

    Therefore, I cannot answer your request based on the provided text.

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