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510(k) Data Aggregation

    K Number
    K971173
    Device Name
    ML DISPOSABLE ALK TUBING
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1997-05-22

    (52 days)

    Product Code
    KYG
    Regulation Number
    886.4360
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ML DISPOSABLE ALK TUBING

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

    For intermittent or continous irrigation, flushing, and cleansing of eyes

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "ML Disposable ALK Tubing". It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot provide the requested information based on the given text. The text does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, or the number/qualifications of experts.
    • Information on adjudication methods.
    • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
    • The type of ground truth used.
    • Information about training sets or how their ground truth was established.
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