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510(k) Data Aggregation

    K Number
    K980985
    Device Name
    SCMD-1000
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1998-05-01

    (45 days)

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

    SCMD-1000

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

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

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) letter for the SCMD-1000 device does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This document is a notification of substantial equivalence and does not detail the technical performance or validation studies of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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