LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991263
    Device Name
    THERMOPLATE
    Manufacturer
    TOKAI HIT CO., LTD.
    Date Cleared
    1999-07-08

    (86 days)

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

    TOKAI HIT CO., LTD.

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

    THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.

    Device Description

    The THERMOPLATE is a device automatically controls the temperature of specimens under the microscopes. The THERMOPLATE is made up of two sections: the plate section and the controller section. The plate section is to be set on the stage of a microscope. The specimen placed on the plate section can be maintained at an optimum temperature by the function of the heating element and the heating control unit. As a clear heating material is being coated inside the plate section, sufficient insulation is provided for the heating mechanism.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves it meets any criteria. The document is a 510(k) summary for a medical device (THERMOPLATE Stage Warmer) and primarily focuses on its description, intended use, and substantial equivalence to a predicate device for regulatory clearance. It mentions "This product's electrical safety and accuracy had been proven by conforming to UL/CE standards" but does not detail the specific acceptance criteria or study results for accuracy, nor does it provide information about sample sizes, ground truth, expert qualifications, or MRMC studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1