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510(k) Data Aggregation

    K Number
    K200567
    Device Name
    ASI Plethysmogrpah Analyzer
    Manufacturer
    Arterial Stiffness Inc.
    Date Cleared
    2021-02-26

    (359 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arterial Stiffness Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.
    Device Description
    The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.
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