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510(k) Data Aggregation

    K Number
    K983500
    Device Name
    PRO2 CHECK OXYGEN INDICATOR
    Manufacturer
    MEDICAL TECHNOLOGY SPECIALISTS, INC.
    Date Cleared
    1999-03-17

    (162 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL TECHNOLOGY SPECIALISTS, INC.

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot describe the acceptance criteria or any study details that prove the device meets those criteria.

    This document is a 510(k) clearance letter from the FDA for a device called "PRO2 Check Oxygen Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria for performance, nor does it detail any studies, performance metrics, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your request.

    The letter focuses on regulatory approval based on substantial equivalence to existing devices, and not on presenting a detailed performance study like what would be found in a clinical trial report or a more comprehensive technical submission.

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