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510(k) Data Aggregation
K Number
K201468Device Name
Pulse Oximeter
Manufacturer
Shenzhen Creative Industry Co., Ltd.
Date Cleared
2021-01-25
(237 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Creative Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.
Device Description
This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.
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K Number
K192343Device Name
Patient Monitor
Manufacturer
Shenzhen Creative Industry Co., Ltd.
Date Cleared
2019-12-31
(125 days)
Product Code
DQA, CCK, DXN, FLL, MWI
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Creative Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
Device Description
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.
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K Number
K172792Device Name
Handheld Pulse Oximeter, Model SP-20
Manufacturer
Shenzhen Creative Industry Co., Ltd.
Date Cleared
2018-11-13
(424 days)
Product Code
DQA, FLL
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Creative Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Handheld Pulse Oximeter is intended for measuring the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.
Device Description
This SP-20 Handheld Pulse Oximeter is an integrated product with a modular design. It simultaneously measures physiological parameters by integrated modules and corresponding accessories. The measurement results are displayed, stored and transferred by the central processing unit. The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.
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K Number
K170047Device Name
All-in-One Health Monitor, PC-303
Manufacturer
Shenzhen Creative Industry Co., Ltd.
Date Cleared
2017-09-09
(247 days)
Product Code
MWI, DQA, DSH, DXN, FLL, NBW
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Creative Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP);
Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement.
This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication.
Device Description
The All-in-One Health Monitor, PC-303 is mobile modular designed patient monitor. It monitors the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
Additionally, the device is also capable to link and communicate with the compatible Blood Glucose Meter and ECG monitor to make the measurement.
This device system measure the patient's physical parameters with variety modules. It takes digital signals from NIBP, SpO2, Temperature module through COM ports, and receives ECG data, blood glucose data from compatible legally marketed ECG Monitor or BLOOD GLUCOSE MONITORING Device. The software to process the data, then display parameters on the screen and storage some useful information.
This device is applicable for use in clinical institutions and has no conditions or factors of contraindication.
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K Number
K150093Device Name
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD.
Date Cleared
2015-06-03
(138 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.
These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are used by adult and pediatric patients. These devices are recommended for use on the index fingers of 1.0 - 2.2 cm thick.
Device Description
A blood-oxygen saturation reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. The reading may be referred to as SaO2. Readings vary from 0 to 100%. Normal readings in a healthy adult, however, range from 94% to 100%. The term SpO2 means the SaO2 measurement determined by pulse oximetry. In its most common (transmissive) application mode, a sensor device is placed on a thin part of the patient's body. The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle and fat. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure SpO2 and body pulse simultaneously.
The PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in a home and clinical environment. The index finger is the recommended site. It is intended for spot-checking adult and pediatric patients on fingers between 1.0 -2.2 cm thick.
This oximeter has a wireless data transmission function. The user can transmit the SPO2 and pulse rate data to a computer through the wireless communication module.
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K Number
K123711Device Name
PATIENT MONITOR
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD
Date Cleared
2013-10-01
(301 days)
Product Code
MWI, CCK, DQA, DXN
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
Device Description
UP-7000 Patient Monitor is a modular designed patient monitor. It monitors the patient's Electrocardiograph (ECG), respiratory rate (RR) and bo dy temperature (TEMP) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method. It can detect the blood oxygen saturation (SpO₂) and pulse rate (PR) non-invasively by the photoelectric method. Finally, it can extend CO2 monitor which measures the End-tidal Carbon dioxide, Inspired CO2 and Respiratory Rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating, the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The alarm activates if the monitored parameters go over the specified limits, alerting the medical professional.
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K Number
K120502Device Name
PC-60NW FINGERTIP OXIMETER
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD
Date Cleared
2012-12-07
(290 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.
Device Description
The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic. The index finger is the recommended site. It is intended for spotchecking adult and pediatric patients on fingers between 1.0 -2.2 . cm thick. This oximeter has the function of wireless data transmission. The user can effectively transmit the data to computer through the wireless communication module.
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K Number
K093016Device Name
VITAL SIGNS MONITOR
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD
Date Cleared
2010-03-30
(182 days)
Product Code
DQA, CCK
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
Device Description
PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.
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K Number
K082055Device Name
MODEL PC-860 FETAL DOPPLER
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD
Date Cleared
2009-02-06
(200 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.
Device Description
This Doppler tests the fetal heart rate through non-invasive ultrasonic Doppler Effect. As is known, ultrasonic wave propagating at a given frequency will be reflected when encountering an obstacle. If it is still an obstacle, the back wave will share the same frequency with the transmitted wave. Once the obstacle moves, the frequency of the back wave will be changed. The higher rate the object moves at, the bigger frequency change will take place. This is the so-called Doppler Effect. With the apparatus, the ultrasonic probe is placed on the abdomen of the pregnant woman. The ultrasonic probe can perceive the fetal heartbeat. When the transmitted wave encounters the fetal heart, the back wave will develop offset frequency. With the offset frequency, the fetal heart rate and frequency can be worked out.
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K Number
K073152Device Name
PC-180 / PRINCE 180 EASY ECG MONITOR
Manufacturer
SHENZHEN CREATIVE INDUSTRY CO., LTD
Date Cleared
2008-01-10
(63 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CREATIVE INDUSTRY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG measuring device for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users (age 18 or older), who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. This Device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended to use with implanted pacemaker.
Device Description
PC-80 / Prince 180 Easy ECG Monitor is a handheld electrocardiograph unit which can measure, display, and store ECG data by the user. The device can calculate the average heart rate and display the heart rhythm after analysis. Furthermore, it's small, light, and easy to use. A 30-second ECG record is measured and stored in this device. The waveform data and heart rate value can be displayed on LCD screen, and those ECG data records can be reviewed.
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