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K Number
K210563
Device Name
Arm Blood Pressure Monitor
Manufacturer
Alicn Medical Shenzhen,Inc
Date Cleared
2021-10-15

(232 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults who over the age of 12.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only refers to the FDA's decision regarding the substantial equivalence of the Arm Blood Pressure Monitor to legally marketed predicate devices. It does not contain information about the device's acceptance criteria, reported performance, or the details of any studies conducted. Therefore, I cannot provide the requested information.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).