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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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