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510(k) Data Aggregation

    K Number
    K123211
    Device Name
    A5 ANESTHESIA DELIVERY SYSTEM
    Manufacturer
    DATASCOPE CORP., PATIENT MONITORING DIVISION
    Date Cleared
    2013-02-14

    (125 days)

    Product Code
    BSZ, CBQ, CBR, CBS, CCK, CCL, NHO, NHP, NHQ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATASCOPE CORP., PATIENT MONITORING DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.
    Device Description
    The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
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    K Number
    K091834
    Device Name
    PASSPORT V MONITOR, MODEL 0998-00-6100
    Manufacturer
    DATASCOPE CORP., PATIENT MONITORING DIVISION
    Date Cleared
    2009-07-15

    (23 days)

    Product Code
    MHX, CCK, DQA, DQK, DSK, DXN, FLL, MSK
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATASCOPE CORP., PATIENT MONITORING DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters: - ECG waveform derived from 3 or 5 lead measurements - Heart Rate derived from selected sources (ECG, SpO2, IBP) - Pulse Oximetry (SpO2 ) - ST Segment Analysis derived from 3 or 5 lead measurements - Arrhythmia Detection derived from 3 or 5 lead measurements - Non Invasive Blood Pressure (NIBP) - Invasive Blood Pressure (IBP) up to two (2) channels . - Carbon Dioxide (CO2) - Respiration Rate derived from ECG or CO2 - Temperature - IV Drug Calculations The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.
    Device Description
    The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.
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    K Number
    K091068
    Device Name
    ACCUTORR V MONITOR, MODEL 0998-00-2000
    Manufacturer
    DATASCOPE CORP., PATIENT MONITORING DIVISION
    Date Cleared
    2009-05-08

    (24 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATASCOPE CORP., PATIENT MONITORING DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), pulse rate and temperature.
    Device Description
    The Accutorr V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Accutorr V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Accutor V may be powered by a rechargeable Lithium ion battery or through line-power. The Accutorr V may be equipped with optional infrared or predictive temperature and recorder modules and may be mounted on an optional rolling stand for easy portability.
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    K Number
    K080175
    Device Name
    NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
    Manufacturer
    DATASCOPE CORP., PATIENT MONITORING DIVISION
    Date Cleared
    2008-06-09

    (137 days)

    Product Code
    BSZ, CLA
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATASCOPE CORP., PATIENT MONITORING DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
    Device Description
    The Navigator Anesthesia Delivery System is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The Navigator System is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the Navigator provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the Navigator System with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional anesthesia system along with dual flow tubes which display the gas flows at all times. The Navigator contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.
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