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510(k) Data Aggregation

    K Number
    K954490
    Device Name
    MERCURY MEDICAL CPR BAG EXHALATION FILTER
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    1996-10-03

    (372 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K883693,K951484,K953687,K911622,K851070
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K883693, K951484, K953687

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

    Not Found

    Device Description

    This device is the combination of two previously cleared devices: the Mercury Medical CPR Resuscitator (K911622) with Filter manufactured by Medicomp (K851070), which has been subsequently tested and supported with independent laboratory data for BFE and VFE.

    AI/ML Overview

    I am sorry, but the provided text is a summary of the 510(k) safety and effectiveness information for a medical device called "Mercury CPR Bag with Filter." It describes the device, its components, and mentions that it's a combination of previously cleared devices with independent laboratory data for BFE and VFE.

    However, the text does not contain any information about a study that reports acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, ground truth establishment, or any details about AI/ML models or comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. The document is a regulatory summary, not a study report.

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