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510(k) Data Aggregation

    K Number
    K974903
    Device Name
    GAS MODULE II, MODEL 0998-00-0143
    Manufacturer
    DATASCOPE CORP.
    Date Cleared
    1998-03-13

    (72 days)

    Product Code
    CBS
    Regulation Number
    868.1620
    Why did this record match?
    Product Code :

    CBS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
    Device Description
    Not Found
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    K Number
    K953795
    Device Name
    VITALMAX 4100
    Manufacturer
    PACE TECH, INC.
    Date Cleared
    1996-07-01

    (322 days)

    Product Code
    CBS
    Regulation Number
    868.1620
    Why did this record match?
    Product Code :

    CBS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960490
    Device Name
    AS/3 COMPACT AIRWAY MODULE M-CAIOV
    Manufacturer
    DATEX MEDICAL INSTRUMENTATION, INC.
    Date Cleared
    1996-05-03

    (91 days)

    Product Code
    CBS
    Regulation Number
    868.1620
    Why did this record match?
    Product Code :

    CBS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AS/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
    Device Description
    The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. It measures carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2) and anesthetic agent concentration (AA) of respiratory gases. The Airway Module also identifies anesthetic agent (ID) and measures airway pressure and volume (pV). The sampled gases are analyzed by an infrared photometer and a paramagnetic oxygen sensor. Respiratory rate is derived from the CO2 signal. The anesthetic agents (halothane, enflurane, isoflurane, desflurane and sevoflurane) are identified from the sampled gases with infrared technique. Airway gas flow is measured with the aid of a pneumotachometer type transducer and airway pressure is measured from the same adapter by means of a pressure transducer.
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