Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210152Device Name
Automatic Digital Blood Pressure Monitor
Manufacturer
AVICHE Shandong Medical Technology Co, Ltd.
Date Cleared
2021-09-23
(245 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
AVICHE Shandong Medical Technology Co, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
Device Description
The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
Ask a Question
Page 1 of 1