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K Number
K212171
Device Name
Electronic Blood Pressure Monitor
Manufacturer
Dongguan Kangweile Electronic Technology Co., Ltd.
Date Cleared
2021-11-01

(112 days)

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

The Electronic Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.

Device Description

Electronic Blood Pressure Monitor

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the Electronic Blood Pressure Monitor. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail performance study results.

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).