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510(k) Data Aggregation

    K Number
    K011861
    Device Name
    BERNOULLI VENTILATOR MANAGEMENT SYSTEM
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    2001-11-06

    (145 days)

    Product Code
    MOD
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K052244,K161411
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

    Device Description

    Bernoulli™ Ventilator Management System

    AI/ML Overview

    The provided text describes a 510(k) clearance for the Bernoulli™ Ventilator Management System but does not contain information about the acceptance criteria, reported device performance, or details of a study demonstrating such performance. It is a regulatory clearance letter and an "Indications for Use Statement".

    Therefore, I cannot provide the requested information.

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