BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER

    K Number: K041694 · Decision Sep 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
    K Number
    K041694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hangzhou Hua'An Medical & Health Instruments Co.,
    Date Received
    June 22, 2004
    Decision Date
    September 13, 2004
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.

    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Hangzhou Hua'An Medical & Health Instruments Co.,

    K Number Device Name
    K122912 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
    K092447 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
    K092514 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
    K041693 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
    K041692 INFRARED EAR THERMOMETER, ET-100 SERIES
    K030361 JASUN, MODELS DT-01F AND DT-11F