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510(k) Data Aggregation

    K Number
    K210937
    Device Name
    Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
    Date Cleared
    2022-05-12

    (409 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alicn Medical Shenzhen, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.
    Device Description
    Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
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    K Number
    K212257
    Device Name
    Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
    Date Cleared
    2022-05-04

    (289 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alicn Medical Shenzhen, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.
    Device Description
    Not Found
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