LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051566
    Device Name
    PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER
    Manufacturer
    PROTON HEALTHCARE LTD.
    Date Cleared
    2006-01-17

    (217 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 Proton Thermometer models PHC 8731, PHC 109 and PHC 889 are intended for measuring body temperature of all ages. The Proton Thermometers are reusable and intended for use in the home setting.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding several thermometer devices. It does NOT contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document confirms that the devices are "substantially equivalent" to legally marketed predicate devices, but it does not include the detailed technical study information you are asking for.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1