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510(k) Data Aggregation

    K Number
    K140020
    Device Name
    HYPERQ ACS-100 SYSTEM
    Date Cleared
    2014-10-28

    (298 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BSP HyperO™ Rest System is intended to be used during rest ECG tests, using the analysis of high frequency components present within the central portion of the QRS complex (HF-QRS). The device outputs a reduced amplitude zone (RAZ) value for the physician to interpret (based on reported clinical study results). The device is indicated for use in the ECG interpretation of patients with acute chest pain presenting to the Emergency Department, aged 18 years and above, as an additional adjunctive aid during initial patient presentation. The significance of the HF-QRS changes and interpretation of the HyperQTM Rest analysis must be determined by a physician, based on the reported clinical study results presented in the device labeling.
    Device Description
    The HyperQTM Rest System measures, processes, stores, and displays information derived from an electrocardiogram (ECG) with a high sampling rate (1000Hz). The device analyzes and records the High Frequency components of the QRS complex of standard ECG (HFQRS). The device displays the HFQRS to the user and also summarizes the analysis to generate an indication whether observed changes are within normal HyperO range, or constitute significant HyperO changes (Reduced Amplitude Zones, a.k.a RAZ); or represent a non-diagnostic test (unreadable). These findings are used as an aid in the clinical evaluation of acute chest pain on initial presentation to the Emergency Department.
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