Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251101
    Device Name
    AIRO Suction Unit (AIRO-01)
    Manufacturer
    CRO, LLC
    Date Cleared
    2025-04-26

    (15 days)

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

    CRO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
    Device Description
    The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
    Ask a Question

    Page 1 of 1