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510(k) Data Aggregation

    K Number
    K994011
    Device Name
    EP MEDSYSTEMS, EP-WORKMATE
    Manufacturer
    EP MEDSYSTEMS, INC.
    Date Cleared
    2000-03-23

    (118 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EP MEDSYSTEMS, EP-WORKMATE

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

    The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding 510(k) clearance for a device named "EP WorkMate Computerized Electrophysiology Recording System". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

    However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe these aspects of a study.

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