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510(k) Data Aggregation

    K Number
    K955577
    Device Name
    ECLIPSE VERSION 3.0
    Manufacturer
    STELLATE SYSTEMS
    Date Cleared
    1996-09-20

    (317 days)

    Product Code
    OLT,OLV
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ECLIPSE VERSION 3.0

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for "Eclipse Version 3.0" (Trade/Device Name: Eclipse Version 3.0, K955577). The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested table and information.

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