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510(k) Data Aggregation

    K Number
    K232338
    Device Name
    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
    Date Cleared
    2023-12-22

    (140 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 are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.
    Device Description
    Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, 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
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    K Number
    K231050
    Device Name
    Arm Blood Pressure Monitor
    Date Cleared
    2023-10-11

    (181 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alicn Medical Shenzhen, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
    Device Description
    Not Found
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    K Number
    K230649
    Device Name
    Arm Blood Pressure Monitor
    Date Cleared
    2023-09-07

    (182 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alicn Medical Shenzhen, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
    Device Description
    Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.
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    K Number
    K222248
    Device Name
    Infrared Thermometer
    Date Cleared
    2023-06-07

    (316 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 Infrared Thermometer (model of AET-R612W.AET-R612G.AET-R612A.AET-R612B.AET-R612C) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from ear canal or non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.
    Device Description
    Not Found
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    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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    K Number
    K210564
    Device Name
    Infrared Thermometer
    Date Cleared
    2022-01-07

    (316 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 Infrared Thermometer (model of AET-R811,AET-R832,AET-R842,AET-R852,AET-R862) is intended for measuring human body temperature of people aged 3 months and above by detecting infract contact with the forehead and ear canal in the home or hospital environment. The Infrared Thermometer (model of AET-R101, AET-R151, AET-R1A3, AET-R1A6, AET-R1C1) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from the ear canal in the home or hospital environment.
    Device Description
    Not Found
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