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510(k) Data Aggregation
K Number
K220651Device Name
Wrist Type Blood Pressure Monitor
Manufacturer
Shenzhen Jamr Medical Technology Co., Ltd
Date Cleared
2022-06-30
(115 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jamr Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure the systolic 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 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 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 three models, which are W02S. W1102. W1102A. All models contain the same software. measurement principle and NIBP algorithm. The main differences are product appearance and the specification of solenoid Valve.
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