K Number
K042265
Date Cleared
2004-08-31

(8 days)

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

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel. The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ) .

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a blood pressure monitor. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the format requested.

The document primarily focuses on the FDA's decision regarding the substantial equivalence of the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL888" to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code. It also includes the intended use for the device.

Therefore, I cannot extract the requested information from the provided text.

§ 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).