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K Number
K050083
Device Name
BLOOD-PRESSURE METER, BPW120
Manufacturer
IDT TECHNOLOGY LIMITED
Date Cleared
2005-04-08

(85 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
K131026
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Device Description

Blood-pressure meter, Model BPW120

AI/ML Overview

The provided document is a 510(k) premarket notification approval letter for a blood pressure meter. It does not contain information about acceptance criteria, study details, or ground truth for an AI/ML device. Therefore, I cannot extract the requested information from this document.

§ 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).