Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072353
    Device Name
    PORTABLE ECSCOPE
    Manufacturer
    DYANSYS CORP
    Date Cleared
    2007-08-30

    (8 days)

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

    DYANSYS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for specific clinical diagnosis. The clinical significance must be determined by a physician.
    Device Description
    Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer. Portable ECScope can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.
    Ask a Question

    Page 1 of 1