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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOPULMONARY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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