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510(k) Data Aggregation

    K Number
    K100660
    Device Name
    INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000
    Manufacturer
    INNOCHIPS TECHNOLOGY CO., LTD.
    Date Cleared
    2010-10-22

    (228 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000

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

    Infrared Ear Thermometer (Dr. Schven ICT-1000) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an Infrared Ear Thermometer (Dr. Schven ICT-1000). It makes a "substantial equivalence" determination but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

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

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