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510(k) Data Aggregation

    K Number
    K042395
    Device Name
    OUTPATIENT III MINOR SURGERY LIGHT
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    2004-12-01

    (90 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OUTPATIENT III MINOR SURGERY LIGHT

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

    The Outpatient® III Minor Surgery Light is designed to provide the required illumination for examinations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, and other health care facilities where the need for additional illumination exists.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical lamp device (Outpatient® III, Minor Surgical Light). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML medical devices.

    Therefore, I cannot provide the requested information. The document solely focuses on regulatory approval based on substantial equivalence to a predicate device, not on analytical or clinical performance studies typically associated with AI/ML device evaluations.

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