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K Number
K171282
Device Name
Fully Automatic Blood Pressure Monitor
Manufacturer
Andon Health Co., Ltd
Date Cleared
2017-07-27

(87 days)

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

KD-7923 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for a blood pressure monitor, not a study report for an AI device. As such, it does not contain the detailed information about acceptance criteria, study methodologies, or AI performance metrics requested.

Therefore, I cannot provide the requested information. The document is a regulatory approval, not a scientific study describing device performance against specific criteria in the way you've outlined for an AI system.

§ 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).