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510(k) Data Aggregation

    K Number
    K070827
    Device Name
    KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2007-05-22

    (57 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K091648
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA SCB Interface Control is a remote control unit for RS-232 compatible medical/non-medical equipment to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.

    Device Description

    The Karl Storz SCB Interface Control is a remote control unit.

    AI/ML Overview

    This document is a 510(k) submission for the Karl Storz SCB Interface Control, a remote control unit. It primarily discusses the device's substantial equivalence to a predicate device and does not contain information regarding studies with acceptance criteria, device performance, sample sizes, expert involvement, or ground truth derivation.

    Therefore, I cannot provide a response that directly answers your request using the provided text. The document is a regulatory filing, not a scientific study report.

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