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510(k) Data Aggregation

    K Number
    K972020
    Device Name
    OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-05-05

    (337 days)

    Product Code
    DXW
    Regulation Number
    870.1270
    Why did this record match?
    Product Code :

    DXW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oscillomate 9001D monitor non-invasively measures the blood pressure of adult and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic and pulse rate.
    Device Description
    The 9001D monitor is compact, lightweight, and durable. The device is housed in and ABS enclosure. The device and all of its accessories are further enclosed in a rugged Cordura nylon carry bag. Power is supplied by an internal rechargeable battery. An external battery charger is provided. Information is displayed in an easy to read LED display. Readings may be taken manually, or at preset intervals from 1 to 60 minutes. A message center display provides information and troubleshooting prompts. A history mode displays previous readings and time readings were taken. The Oscillometric technique monitors the changes of pressure caused by the flow of blood through the artery. The monitor will inflate the cuff around the patients arm to a value that occludes the artery. The monitor then deflates the cuff in steps. As the cuff pressure goes down, blood continues to flow through the artery. The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. As the monitor steps down further, the pulses will reach a peak amplitude and then start to decrease with additional pressure steps. The rising and falling of the amplitude of these pressure pulses as the cuff pressure is stepped down, creates a curve that is used to find the systolic pressure and diastolic pressure. Counting the pulses over a time period will give a pulse rate. Motion artifact rejection techniques are used to provide accurate results under most operating conditions.
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    K Number
    K955887
    Device Name
    NEWMED ABP-LITE
    Manufacturer
    NEWMED CORP.
    Date Cleared
    1996-09-05

    (252 days)

    Product Code
    DXW
    Regulation Number
    870.1270
    Why did this record match?
    Product Code :

    DXW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ABP-lite is to detect, diagnose, and monitor hypertension.
    Device Description
    The ABP-lite is a 24-hour Ambulatory Blood Pressure Monitoring System (ABPMS) which obtains and stores the results of repeated determinations of blood pressure and heart rate during the activities of ordinary daily living. The ABP-lite system also manages a patient data base. The ABP-lite ABPMS includes a pneumatic cuff (worn by the patient), Data Recorder Unit (worn by the patient -- collects blood pressure ("BP") and heart rate ("HR") data), Remote Control Unit (LCD display of BP and HR data as well as error codes, patient control functions of event button and stop ongoing test). Interface Unit (interface between Remote Control Unit and PC), and ABPM-Soft Analyzer (proprietary custom software used for initial setup of Data Recorder, plus download, processing and printing of collected data). The ABP-lite system weighs 13 ounces and is 21 cubic inches in size. The ABP-lite system uses the Korotkoff and oscillometric methods of blood pressure measurement with blood pressure cuff and microphone technology. Safety systems include an emergency pressure release system and watchdog timer.
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