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510(k) Data Aggregation

    K Number
    K111013
    Device Name
    ACEM
    Manufacturer
    SANDHILL SCIENTIFIC, INC.
    Date Cleared
    2011-12-19

    (252 days)

    Product Code
    FFZ, JOM, MYE
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FFZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plethysmography Module: The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography. Electrogastrography (EGG) Module: A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.
    Device Description
    The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized. The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized. Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.
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