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510(k) Data Aggregation

    K Number
    K083377
    Device Name
    ACCUPEN
    Manufacturer
    ACCUTOME ULTRASOUND, INC.
    Date Cleared
    2009-07-27

    (255 days)

    Product Code
    HKX,HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUPEN

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

    The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or details of any studies conducted for the AccuPen device. The documents are limited to a 510(k) clearance letter and an Indications for Use statement. Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study-related details.

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