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510(k) Data Aggregation
K Number
K231478Device Name
Digital Blood Pressure Monitor (Model: YB-800)
Manufacturer
Date Cleared
2023-12-15
(207 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Wenzhou Yosun Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable CUFF (22-32cm) is wrapped around the upper arm at medical facilities or at home, it's supplied for OTC use.
Device Description
The arm-type electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. This equipment is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and an LCD liquid crystal display.
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