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510(k) Data Aggregation

    K Number
    K991625
    Device Name
    KOMET XK-95 PERFORATOR MOTOR (MI-102)
    Manufacturer
    KOMET MEDICAL
    Date Cleared
    1999-07-30

    (80 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KOMET XK-95 PERFORATOR MOTOR (MI-102)

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

    The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) clearance letter for the Komet Medical Xk-95 Perforator Motor. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that are typically found in a clinical study report.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory and not a performance-based assessment.

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