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510(k) Data Aggregation

    K Number
    K081266
    Device Name
    MERCURY MEDICAL PEEP VALVE
    Manufacturer
    MERCURY ENTERPRIZES DBA MERCURY MEDICAL
    Date Cleared
    2009-03-05

    (304 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCURY ENTERPRIZES DBA MERCURY MEDICAL

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

    The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a PEEP Valve, indicating that the device has been found substantially equivalent to a predicate device. It defines the device's indications for use but does not detail specific acceptance criteria, study methodologies, or performance results.

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