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510(k) Data Aggregation

    K Number
    K982487
    Device Name
    CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
    Manufacturer
    CARDIOPULMONARY TECHNOLOGIES, INC.
    Date Cleared
    1998-10-14

    (89 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Meteor is a handheld respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport, either land or air. It is intended for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. Meteor can be used for either continuous (Meteor 200) or spot check usage (Meteor 100 and 200). It is not intended to be used as an apnea monitor. No alarms are provided.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a respiratory mechanics monitor, but it does not detail the acceptance criteria, specific study design, or performance metrics of the device. It primarily discusses regulatory aspects and allows the device to be marketed.

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