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510(k) Data Aggregation

    K Number
    K070926
    Device Name
    ELECTRODE/EXTENSION CABLES, MODELS ATAR
    Manufacturer
    Oscor Inc.
    Date Cleared
    2007-06-07

    (65 days)

    Product Code
    IKD
    Regulation Number
    890.1175
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECTRODE/EXTENSION CABLES, MODELS ATAR

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

    Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

    Device Description

    Electrode/Extension Cables, Models ATAR™

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for Electrode/Extension Cables. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device's AI or algorithmic component.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This document is a regulatory approval letter, not a study report.

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