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    K Number
    K970886
    Device Name
    HANAULUX BLUE 80 HOSPITAL
    Manufacturer
    HERAEUS MED GMBH
    Date Cleared
    1997-04-16

    (69 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K954169
    Why did this record match?
    Device Name :

    HANAULUX BLUE 80 HOSPITAL

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

    Not Found

    Device Description

    Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.

    AI/ML Overview

    This document describes a medical device, the HANAULUX blue 80 Hospital, which is an examination and surgical stand light. It does not describe an AI/ML powered device or a study involving such a device.

    Therefore, I cannot provide the requested information regarding:

    • Acceptance criteria and reported device performance related to a study. The document confirms compliance with safety standards (UL 2601, IEC 601-1, UL 153) and states a maximum UV irradiance (
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