BEUDAMED
    Product Code: ONZ FDA class 2 21 CFR 868.5895

    Mechanical Ventilator

    Anesthesiology

    The Mechanical Ventilator (product code ONZ) is a Class 2 anesthesiology device regulated under 21 CFR 868.5895 in the Anesthesiology specialty (AN), cleared via 510(k). It is a volume assist ventilator designed for adult patients with respiratory insufficiency who can spontaneously breathe a minimum tidal volume of 3.5 cc/kg of predicted body weight, intended for continuous use during patient ambulation, physical therapy, and rehabilitation in institutional or home care environments under physician direction. The device is not flagged as an implant or life-sustaining in the FDA record, though it supports respiratory function.

    View on FDA
    510(k)s
    6
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    3
    Years Active
    7

    Basic Information

    Product Code
    ONZ
    Device Class
    FDA class 2
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K152664 TAV System
    K131562 BREATHE NIOV VENTILATION SYSTEM
    K103345 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
    K102525 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
    K100528 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
    K082982 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.