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    K Number
    K250837
    Device Name
    Pulse Oximeter
    Manufacturer
    Shanghai Berry Electronic Tech Co., Ltd
    Date Cleared
    2025-09-25

    (189 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K181503
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child users in hospitals, hospital facilities and home healthcare environments.

    Device Description

    The Pulse Oximeter model BM20, can display the SpO2 and PR, plethysmogram wave and other indication parameters, such as pulse battery power status and the PI. The model BM20 Pulse Oximeter include the mainboard, display and lithium battery. It has small size, light weight, easy to carry. It adopts low power consumption design, and has the function of battery capacity display.

    The pulse oximeter, model BM20, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults, pediatric and adolescent patients in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios. This medical device can be reused. Not for continuously monitoring.

    AI/ML Overview

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