(131 days)
The blood pressure meter Models: XJ-2001AC, XJ-2002AS and XJ-2003A are non-invasive blood pressure measurement systems which are intended to measure the diastolic and systolic blood pressure, pulse rate of the adult individual through using inflatable cuff at home. The cuff circumference is limited to 8.6614 inches to 12.60 inches.
Blood Pressure Meter Model: XJ-2001AC, XJ-2002AS and XJ-2003A
The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a blood pressure meter. It does not contain the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications based on the provided text. This document confirms the device's clearance based on substantial equivalence to a predicate device, not on specific performance data presented in a study.
§ 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).