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510(k) Data Aggregation

    K Number
    K232975
    Device Name
    Pulse Oximeter (MD300C228)
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2024-06-21

    (274 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The device can be used by the people whose finger thickness is between 8mm and 22mm(0.3 inches to 0.9 inches).
    Device Description
    The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. The MD300C228 is adopted LCD screen to display to display SpO2, Pulse Rate value (PR), Perfusion Index (PI), pulse bar, brightness level, battery indicator, signal indicator and waveform, it has 7 display modes, the brightness level can be adjusted 1-5 level. The measured data can be transmitted to APP through Bluetooth. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LCD display screen, user interface and button control circuit. Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660mm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel. The subject device is not for life-supporting or life-sustaining, not for implant. The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products.
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    K Number
    K230587
    Device Name
    Wrist Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2023-11-30

    (273 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use. The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
    Device Description
    The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission. Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment. The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module. Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
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    K Number
    K230172
    Device Name
    Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2023-08-12

    (204 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
    Device Description
    The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit. Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel. The subject device is not for life-supporting or life-sustaining, not for implant. The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products.
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    K Number
    K220101
    Device Name
    Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2023-03-08

    (420 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).
    Device Description
    The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted 1-10 level. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. The enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile, and the transducers are reusable and do not need sterilization. The device is for prescription. The device does not contain drug or biological products.
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    K Number
    K221992
    Device Name
    Electronic Pulse Stimulator
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2022-10-21

    (107 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.
    Device Description
    The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness. Its accessories include connecting wires, electrode pads, 2 AAA batteries. The device is for over the counter use. The device does not contain drug or biological products. The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.
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    K Number
    K211400
    Device Name
    Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2022-02-11

    (282 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients. Respiratory rate (RR) is intended for adults only. The Pulse Oximeter is intended for use in hospitals, hospital-type facilities and homecare environment. The Pulse Oximeter is not intended for patients with: - cardiopulmonary disease - cardiac dysrhythmias, unstable patients, or patients in the ICU - respiratory insufficiency or recovering from surgery or trauma - morbid obesity - severe arrhythmia The Pulse Oximeter is not intended for patients who are: - injured, disabled or physically deformed - pregnant or lactating - taking drugs that stain the blood. The Pulse Oximeter is not designed to detect apneas.
    Device Description
    The proposed device Fingertip Pulse Oximeter MD300CI218R is a battery powered device. It can detect and display the measured %SpO2 ,pulse rate,respiratory rate and perfusion index and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR , respiratory rate, perfusion index, and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power mav be low. The proposed device is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients, respiratory rate (RR) for adult in hospital-type facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information. The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in software.
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    K Number
    K211752
    Device Name
    Infrared Thermometer
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2022-01-21

    (228 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer is a reusable thermometer intended for the intermittent determination of human body temperature in a non-contact mode using the center of the forehead as the measurement site on people of all ages. It can be used by consumers in the household environment and by healthcare provider.
    Device Description
    The infrared thermometer uses infrared temperature sensor to detect infrared energy radiated from the forehead. The intensity of the emitted energy depends on the temperature of the object. The infrared probe can recognize the emitted energy and transfer it to an electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to a temperature reading, which is displayed on the screen. This is a continuous non-invasive method of measuring body temperature. After measuring the forehead temperature with an infrared temperature sensor, the calculated temperature value is obtained. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over-the-counter use. The Infrared Thermometer, Model CFT-308, consists of the following parts: a) Infrared sensor b) Integrated circuit c) Microprocessor (with Bluetooth function) (Bluetooth transmission is optional) d) OLED display e) Buzzer f) 2 Buttons ("Start" button, "Measuring" button) g) Alkaline batteries; size AAA, 2 x 1.5 V h) Lens
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    K Number
    K211754
    Device Name
    Vital Signs Monitor
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2021-11-15

    (161 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.
    Device Description
    The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm.
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    K Number
    K181503
    Device Name
    Fingertip Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2018-10-11

    (126 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.
    Device Description
    The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low. The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information. The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in software.
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    K Number
    K172366
    Device Name
    Wrist Pulse Oximeter
    Manufacturer
    Beijing Choice Electronic Technology Co., Ltd.
    Date Cleared
    2018-03-16

    (224 days)

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

    Beijing Choice Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.
    Device Description
    The proposed devices Wrist Pulse Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission. The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.
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