LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971831
    Device Name
    QUICK CHECK INSTANT THERMOMETER
    Manufacturer
    EJB MEDICAL, INC.
    Date Cleared
    1998-05-07

    (356 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

    THIS DEVICE IS INTENDED TO BE USED PHIN IT IS DESIRED TO MEASURE & PERSON'S BODY TEMPERATURE.

    Device Description

    QUICK CHECK INSTANT THERMOMETER

    AI/ML Overview

    This document is a 510(k) clearance letter for the Quick Check Instant Thermometer, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study demonstrating the device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1