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510(k) Data Aggregation

    K Number
    K202009
    Device Name
    Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
    Manufacturer
    Shenzhen Juzhong Technology Co., Ltd
    Date Cleared
    2021-03-22

    (244 days)

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

    Shenzhen Juzhong Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.
    Device Description
    The Probe Cover is a plastic covering used for oral/axillary digital thermometer. This device is not made with natural rubber latex. Refer to user manual for the recommend thermometers that probe covers can be used with.
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