LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030361
    Device Name
    JASUN, MODELS DT-01F AND DT-11F
    Manufacturer
    HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
    Date Cleared
    2003-02-21

    (18 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 :

    JASUN, MODELS DT-01F AND DT-11F

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

    The devices models DT-01Fand DT-11F are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

    Device Description

    Digital Thermometer Model DT-01F & DT-11F

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a digital thermometer. It confirms the device's substantial equivalence to legally marketed predicate devices. However, it does not contain the detailed information necessary to complete the acceptance criteria table or descriptions of a study proving the device meets those criteria. The provided text is primarily administrative and regulatory.

    Therefore, I cannot fulfill your request for the acceptance criteria table and study details based on the given input. The document does not describe performance specifications, test methods, sample sizes, expert qualifications, or ground truth establishment.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1