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510(k) Data Aggregation

    K Number
    K172141
    Device Name
    Pulse Oximeter
    Manufacturer
    Shanghai Berry Electronic Tech Co., Ltd
    Date Cleared
    2018-04-04

    (261 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Berry Electronic Tech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
    Device Description
    The proposed device, pulse oximeter, includes two models in this application, BM1000C. The two proposed devices all are fingertip device; they are share the following same features: - Spot check and display SpO2 and PR value; - Low battery capacity indicator; - Finger off indicator; - wireless connection function Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function. The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. The proposed device is not provided sterile and is not a reprocessed single-use device.
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    K Number
    K142687
    Device Name
    Pulse Oximeter
    Manufacturer
    Shanghai Berry Electronic Tech Co., Ltd
    Date Cleared
    2015-04-13

    (203 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Berry Electronic Tech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
    Device Description
    The proposed device, pulse oximeter, includes two models in this application, BM1000A and BM2000A. The two proposed devices all are handheld device with detachable SpO2 sensor, the BM1000A work with the SpO2 sensor BSA09001P and the BM2000A work with the SpO2 sensor BST09001S; they share the following same features: ★ Spot check and display SpO2 and PR value; ★ Low battery capacity indicator; ★ Finger off indicator; The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. The proposed device is not provided sterile and is not a reprocessed single-use device.
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