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510(k) Data Aggregation

    K Number
    K974253
    Device Name
    CPD COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1998-02-25

    (104 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CPD COMMANDER

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

    Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to SCIERAN TECHNOLOGIES, INC. for their device, CPD COMMANDER. It states that the device is substantially equivalent to legally marketed predicate devices and can be brought to market. However, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses regulatory approval and classification.

    Therefore, I cannot extract the requested information from the provided text.

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