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510(k) Data Aggregation

    K Number
    K955026
    Device Name
    AS/3 NMT MODULE
    Manufacturer
    DATEX MEDICAL INSTRUMENTATION, INC.
    Date Cleared
    1997-04-28

    (543 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX MEDICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
    Device Description
    The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient. The NMT measurement hardware is in the NMT Module stimulates the Mores the patient controlled by the Net Compact Monitor central unit. The News NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX MEDICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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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?
    Applicant Name (Manufacturer) :

    DATEX MEDICAL INSTRUMENTATION, INC.

    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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