Search Results
Found 1 results
510(k) Data Aggregation
K Number
K241129Device Name
Upper Arm Electronic Blood Pressure Monitor
Manufacturer
ShenZhen GoodlyMed Technology Co., Ltd.
Date Cleared
2024-07-03
(70 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ShenZhen GoodlyMed Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.
Device Description
The Upper Arm Electronic Blood Pressure Monitor uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a " zero pressure" equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsation , which is used to determine the systolic and diastolic pressure, and also pulse rate.
Ask a Question
Page 1 of 1