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510(k) Data Aggregation

    K Number
    K221676
    Device Name
    Exsalta
    Manufacturer
    Date Cleared
    2022-09-16

    (99 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRW Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient
    Device Description
    Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use.
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    K Number
    K172284
    Device Name
    NAPA LP-15 Airway Pressure Monitor
    Manufacturer
    Date Cleared
    2018-02-09

    (196 days)

    Product Code
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRW Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
    Device Description
    The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
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