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510(k) Data Aggregation

    K Number
    K981469
    Device Name
    CERMAX300 LIGHTSOURCE
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-07-09

    (77 days)

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

    CERMAX300 LIGHTSOURCE

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

    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

    Device Description

    Lightsource or illuminator CERMAX300

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Cermax300 Lightsource." It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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