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    K Number
    K992425
    Device Name
    TES-20
    Manufacturer
    TES ELECTRICAL ELECTRONIC CORP.
    Date Cleared
    1999-10-19

    (90 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TES ELECTRICAL ELECTRONIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.

    Device Description

    Tes Electrical Electronic Corp. TES-20 Holter ECG Recorder

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking about. The document is an FDA letter acknowledging the substantial equivalence of the TES-20 Holter ECG Recorder to a legally marketed predicate device, allowing it to be marketed. It does not include information on specific performance metrics, test methodologies, or clinical study results.

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