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510(k) Data Aggregation

    K Number
    K974598
    Device Name
    MICROKERATOME OR THE MATE
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1998-04-22

    (134 days)

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

    MICROKERATOME OR THE MATE

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

    The MMK-1000 is designed to produce a corneal flap.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a microkeratome device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document confirming the device's substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the given input.

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