LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080593
    Device Name
    FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2008-04-02

    (30 days)

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

    The Fora Comfort 4 in 1 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the "Fora Comfort 4 in 1 Ear Thermometer" and an "Indications for Use" statement. This document does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The provided text is a regulatory approval document, not a detailed technical report of performance studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1