(174 days)
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
Not Found
This document is a 510(k) clearance letter from the FDA for a Blood Pressure Monitor. It does NOT contain information about an AI/ML medical device, nor does it describe an acceptance criteria study with the requested details.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set information.
The provided text focuses on the regulatory clearance process for a standard medical device (blood pressure monitor), detailing regulations, marketing provisions, and administrative contact information.
§ 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).