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510(k) Data Aggregation

    K Number
    K042002
    Device Name
    SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
    Manufacturer
    ELA MEDICAL INC
    Date Cleared
    2004-10-20

    (86 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELA MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView™ Holter ECG recorder (K032466), - - SyneFlash™ Holter ECG (K990727), or ﺴ - other compatible cassette tape recorder. - In addition, any ISHNE compatible recording can be read by SyneScope™ EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView™ Holter ECG recorder (K032466), - - SyneFlash™ Holter ECG (K990727), or - - other compatible cassette tape recorder. - SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView™ Holter ECG recorder (K032466), - - SyneFlash™ Holter ECG (K990727) - HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ . SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following: - Patient symptoms such as syncope, dizziness or palpitations. . - Ischemia, especially in patients who cannot exercise or in patients with variant . angina. - Function of an implanted pacemaker or defibrillator. .
    Device Description
    SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only). SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.
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