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510(k) Data Aggregation

    K Number
    K961063
    Device Name
    AS/3 CARDIAC OUTPUT & SVO2 MODULE
    Manufacturer
    DATEX MEDICAL INSTRUMENTATION, INC.
    Date Cleared
    1996-05-31

    (74 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K922876
    Why did this record match?
    Device Name :

    AS/3 CARDIAC OUTPUT & SVO2 MODULE

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

    The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.

    Device Description

    The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Datex AS/3™ Cardiac Output and SvO2 Module). It describes the device, its intended use, and its measurement techniques. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow for the completion of the requested table and study description.

    Therefore, I cannot provide the requested information based on the input text. The 510(k) summary primarily focuses on the description and equivalence to previously cleared devices, not on the detailed clinical validation studies and their results.

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