(62 days)
The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
Fully Automatic Blood Pressure Monitor Model: LD-535 & LD-539
The provided text is an FDA 510(k) clearance letter for an automatic digital blood pressure monitor. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table and information based on the given input.
§ 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).