LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972727
    Device Name
    CBALK-1000 BLADE
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1997-10-10

    (81 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CBALK-1000 BLADE

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

    The CBALK-1000 blades are to be used with the Chiron Microkeratome.

    Device Description

    CBALK-1000 Blades

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the CBALK-1000 Blades manufactured by Howard Instruments, Inc. This letter determines substantial equivalence to a predicate device, allowing the product to be marketed.

    However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria. It is a regulatory clearance, not a performance study report.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1