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510(k) Data Aggregation

    K Number
    K151357
    Device Name
    MIRI TL
    Manufacturer
    AT MEDICAL UAB
    Date Cleared
    2016-04-22

    (338 days)

    Product Code
    MQG,MQK
    Regulation Number
    884.6120
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MIRI TL

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

    To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

    Preparing, storing and transferring human embryos. To be used only with the MIRI TL device.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for two devices: AT Medical MIRI TL and AT Medical CultureCoin. It does not contain information on device acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot fulfill your request with the provided information.

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