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510(k) Data Aggregation

    K Number
    K982793
    Device Name
    PIEZO TRONIC
    Date Cleared
    1998-10-28

    (79 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Piezo Tronic is an ultrasonic scaler intended for use during dental cleaning and periodontal (gum) therapy to remove plaque and calculus and ultrasonic vibrating scaler tip to the teeth.
    Device Description
    The Piezo Tronic consists of a main chassis containing a water control valve, an electric power supply, controls and displays, and ultrasonic generator. A footswitch is connected to the main chassis by a footswitch cord and a handpiece containing an ultrasonic scaler tip is connected to the main chassis by a handpiece cord. When a dental professional has placed the tip in the proper position, the footswitch is depressed which activates the ultrasonic generator and opens the control valve to initiate water flow. The water flow and the level of ultrasonic energy delivered can be adjusted via operator accessible controls. A circular knob with an inked line on the front panel indicates the power level currently selected. Power level is adjusted by rotating the labeled knob clockwise on the front panel. Water flow is adiusted via a knob also on the front panel. When the foot switch is released, both ultrasonic energy and water flow stop immediately. Safety of the operator and patient is ensured by compliance to IEC 601-1 and EMC 89/336/CEE.
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    K Number
    K960337
    Device Name
    AMD HOME HEALTH MONITORING SYSTEM
    Date Cleared
    1996-09-24

    (244 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood
    Device Description
    The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. The AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor. The AMD Home Health Glucose Monitor testing system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration. The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose Monitor. This device allows remote clinical review of test results obtained in the patient's home.
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