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510(k) Data Aggregation

    K Number
    K001763
    Device Name
    CRIT-LINE MONITOR III (CLM III)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    2000-12-20

    (191 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992227
    Device Name
    CRIT-LINE MONITOR III (CLM III)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1999-07-30

    (28 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRIT-LINE MONITOR III, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
    Device Description
    The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
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    K Number
    K983551
    Device Name
    CRIT-SCAN II MONITOR
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1999-05-27

    (230 days)

    Product Code
    GKF, MAR
    Regulation Number
    864.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the CRIT-SCAN II Monitor is as a continuous, non-invasive hematocrit-measuring device whereby a physician could use the information to determine the anemic state of the patient. The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device.
    Device Description
    The CRIT-SCAN II consists of state-of-the-art optoelectronics which, when combined with custom software, has the ability to measure hematocrit transcutaneously (i.e. through a patient's middle finger or index finger). The patient's finger is placed into a custom designed cuff which, when filled with air, creates the necessary perfusion for the optoelectronics to take a hematocrit reading.
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    K Number
    K982412
    Device Name
    MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1998-10-09

    (88 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
    Device Description
    The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
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    K Number
    K972470
    Device Name
    CRIT-LINE MONITOR (CLMIII)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1997-12-11

    (163 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
    Device Description
    The CLMIII consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber.
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    K Number
    K953875
    Device Name
    CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1996-07-23

    (391 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN-LINE DIAGNOSTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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