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510(k) Data Aggregation

    K Number
    K051233
    Device Name
    OMRON MODEL 514N TYMPANIC THERMOMETER
    Manufacturer
    OMRON HEALTHCARE, INC.
    Date Cleared
    2005-06-21

    (39 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Special
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K051255
    Why did this record match?
    Reference Devices :

    K051255

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

    Intermittent temperature measurement of the neonatal, pediatric and adult population through the patient's auditory canal using a battery operated infrared sensor.

    Device Description

    OMRON Tympanic Thermometer, Model MC-514N

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the OMRON Tympanic Thermometer, Model MC-514N. It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter and the accompanying "Indications for Use Statement" do not contain any information regarding specific acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and detailed information based on the provided text. The document is solely an FDA clearance letter and not a technical study report.

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