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510(k) Data Aggregation
K Number
K233823Device Name
Ultrasonic Fetal Doppler
Manufacturer
Shenzhen Jamr Technology Co., Ltd.
Date Cleared
2024-06-28
(210 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.
Device Description
Not Found
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K Number
K233146Device Name
Blood Pressure Monitor
Manufacturer
Shenzhen Jamr Technology Co., Ltd.
Date Cleared
2024-03-19
(174 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
Device Description
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K Number
K230409Device Name
Wrist Type Blood Pressure Monitor (W05,W1101L)
Manufacturer
Shenzhen Jamr Technology Co., Ltd.
Date Cleared
2023-08-25
(191 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
Device Description
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.
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K Number
K200437Device Name
Blood Pressure Monitor
Manufacturer
Shenzhen Jamr Technology Co., Ltd.
Date Cleared
2020-06-25
(122 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
Device Description
The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
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