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510(k) Data Aggregation

    K Number
    K971064
    Device Name
    BAYERS BIMANUAL I/A HANDPIECES
    Manufacturer
    VISION CARE DEVICES, INC.
    Date Cleared
    1997-06-09

    (77 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAYERS BIMANUAL I/A HANDPIECES

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

    Anterior Phaco emulsification cortex clean up.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "Bayers Bimanual I/A Handpieces." This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or higher-risk device requiring a PMA.

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

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