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510(k) Data Aggregation

    K Number
    K241578
    Device Name
    Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
    Manufacturer
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Cleared
    2025-02-19

    (261 days)

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

    Shenzhen BSX Technology Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Digital Blood Pressure Monitor (Model: BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.
    Device Description
    The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor that uses the cuff oscillometric method to measure diastolic and systolic blood pressure and pulse rate. It has an LCD digital display, is powered by two "AAA" batteries, and uses automatic inflation with an electric pump and automatic rapid deflation valve.
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    K Number
    K230097
    Device Name
    IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
    Manufacturer
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Cleared
    2023-04-06

    (83 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen BSX Technology Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
    Device Description
    IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.
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    K Number
    K202296
    Device Name
    Infrared Forehead Thermometer, Model BSX976
    Manufacturer
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Cleared
    2021-07-23

    (344 days)

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

    Shenzhen BSX Technology Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants.
    Device Description
    BSX976 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, directly show on the LCD screen. - The device is widely used for home healthcare, medical institutes, and many other occasions. - The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. - It focuses the infrared from the human's forehead by the Fresnel lens.
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    K Number
    K202324
    Device Name
    Fingertip Pulse Oximeter
    Manufacturer
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Cleared
    2020-12-14

    (119 days)

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

    Shenzhen BSX Technology Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
    Device Description
    The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. The differences between different models only includes the color of the non-patient contacting shell part and the size. And the color display screen of BSX221/BSX223/BSX261/BSX263/BSX281/BSX283 is OLED, while that of BSX231/BSX233/BSX251/BSX253 is TFT.
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    K Number
    K183058
    Device Name
    Arm-type Electronic Blood Pressure Monitor
    Manufacturer
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Cleared
    2019-07-03

    (243 days)

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

    Shenzhen BSX Technology Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
    Device Description
    The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523 is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The difference between the six models include the battery type and the backlight indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion Battery. Moreover, the subject device is equipped with backlight indicator except models BSX516 and BSX525. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed Arm-type Electronic Blood Pressure Monitor share the similar software, measurement principle and NIBP algorithm. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
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