BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Vicks VNT200 No Touch Forehead Thermometer

    K Number: K193213 · Decision Apr 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    159

    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
    Vicks VNT200 No Touch Forehead Thermometer
    K Number
    K193213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaz USA, Inc., A Helen of Troy Company
    Date Received
    November 21, 2019
    Decision Date
    April 28, 2020
    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 Kaz USA, Inc., A Helen of Troy Company

    K Number Device Name
    K212609 BHA100 Series Braun Clear Hearing Aid
    K180131 Vicks RapidRead Digital Thermometer
    K181242 Braun BNT400 No Touch + Forehead Thermometer
    K181015 Braun BFH175 Infrared Forehead Thermometer
    K163516 Braun No Touch + Forehead NTF3000 Thermometer
    K161933 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
    K152975 VDT985US Vicks SmartTemp Thermometer