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510(k) Data Aggregation

    K Number
    K970769
    Device Name
    COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
    Manufacturer
    ARISTO MEDICAL
    Date Cleared
    1997-08-28

    (178 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

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

    Continuous or spot monitoring of non-invasive arterial oxygen saturation.

    Device Description

    ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA concerning the substantial equivalence of the ComSat Oximeter Sensors to a legally marketed predicate device. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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