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510(k) Data Aggregation

    K Number
    K081061
    Device Name
    HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
    Manufacturer
    HARVARD MEDICAL DEVICES LTD.
    Date Cleared
    2008-07-18

    (95 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

    Device Description

    IR Ear Thermometer HMIRET-002/Kinetik Branded IET-1 Series

    AI/ML Overview

    The provided text describes an FDA 510(k) premarket notification for an IR Ear Thermometer. It does not contain the specific details about acceptance criteria, device performance, or the study used to prove the device meets those criteria. The document is primarily an FDA clearance letter, confirming substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table and study details. This information would typically be found in the 510(k) summary or a more detailed technical report submitted to the FDA, which is not present in the provided text.

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