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510(k) Data Aggregation
K Number
K220886Device Name
Upper Arm Type Blood Pressure Monitor
Manufacturer
Date Cleared
2022-07-27
(121 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Upper Arm Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate 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
The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed 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 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.
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