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

    Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

    K Number: K212257 · Decision May 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    11
    Review Days
    289

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    Basic Information

    Device Name
    Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
    K Number
    K212257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alicn Medical Shenzhen, Inc.
    Date Received
    July 19, 2021
    Decision Date
    May 4, 2022
    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

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    Other Clearances by Alicn Medical Shenzhen, Inc.

    K Number Device Name
    K232338 Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
    K231050 Arm Blood Pressure Monitor
    K230649 Arm Blood Pressure Monitor
    K222248 Infrared Thermometer
    K221913 Arm Blood Pressure Monitor
    K210937 Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
    K210565 Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
    K212877 Arm Blood Pressure Monitor
    K210564 Infrared Thermometer
    K210563 Arm Blood Pressure Monitor
    Search all 11 clearances from Alicn Medical Shenzhen, Inc. →