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510(k) Data Aggregation

    K Number
    K120931
    Device Name
    CRITICAL CARE VENTILATOR
    Manufacturer
    ORICARE, INC.
    Date Cleared
    2013-06-06

    (436 days)

    Product Code
    CBK,BTI,BTT,CCK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

    The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.

    The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.

    The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.

    The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.

    Device Description

    The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (Oricare V8800 Critical Care Ventilator) and an "Indications for Use Statement."

    While it confirms the device's regulatory clearance and intended use, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment details as requested in your prompt.

    Therefore, I cannot extract the information needed to fill out your table and elaborate on the study details.

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