Search Results
Found 6 results
510(k) Data Aggregation
K Number
K191279Device Name
Disposable SpO2 Sensor
Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.
Date Cleared
2019-12-06
(207 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Caremed Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.
Device Description
The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
Ask a Question
K Number
K182751Device Name
Reusable Temperature Probe
Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.
Date Cleared
2019-09-06
(343 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Caremed Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.
Device Description
Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.
These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.
Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".
Ask a Question
K Number
K182755Device Name
Disposable Temperature Probe
Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.
Date Cleared
2018-12-21
(84 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Caremed Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rectal Temperature Probe:
The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
Skin Temperature Probe:
The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
Device Description
Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.
These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.
Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".
Ask a Question
K Number
K182433Device Name
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.
Date Cleared
2018-12-17
(102 days)
Product Code
DXQ, DXO
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Caremed Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Device Description
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.
The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.
The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.
The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
The reusable blood pressure cuff is reusable device, and which is made of PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.
The reusable blood pressure cuff has 16 models with different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
Ask a Question
K Number
K153184Device Name
Caremed Reusable & Disposable SPO2 Sensors
Manufacturer
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2017-01-04
(428 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities
Device Description
Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.
Ask a Question
K Number
K153188Device Name
Caremed patient cable and leadwires
Manufacturer
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2016-10-24
(356 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Device Description
The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
Ask a Question
Page 1 of 1