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510(k) Data Aggregation

    K Number
    K040862
    Device Name
    GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
    Manufacturer
    CARADYNE, LTD.
    Date Cleared
    2004-06-30

    (89 days)

    Product Code
    BZD, CBK
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARADYNE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.
    Device Description
    The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients
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    K Number
    K023565
    Device Name
    OXICHECK
    Manufacturer
    CARADYNE, LTD.
    Date Cleared
    2003-03-28

    (156 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARADYNE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.
    Device Description
    The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.
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    K Number
    K000959
    Device Name
    CRITERION 60 OR PM 60
    Manufacturer
    CARADYNE, LTD.
    Date Cleared
    2000-06-22

    (90 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARADYNE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992101
    Device Name
    CRITERION 40 OR PM 40
    Manufacturer
    CARADYNE, LTD.
    Date Cleared
    2000-01-06

    (198 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARADYNE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.
    Device Description
    The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector.
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    K Number
    K982283
    Device Name
    WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
    Manufacturer
    CARADYNE, LTD.
    Date Cleared
    1999-03-09

    (252 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARADYNE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
    Device Description
    The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 140 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube.
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