(104 days)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
Not Found
This document is an FDA 510(k) clearance letter for an Arm Blood Pressure Monitor. It primarily covers administrative details, regulatory classifications, and general compliance requirements. It does not contain the detailed acceptance criteria or study results for device performance that would be found in a clinical study report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested information based on the provided text. The document is essentially a regulatory approval notice, not a technical performance report.
To answer your prompt, I would need a different type of document, such as:
- A clinical study report
- A premarket submission summary (e.g., a 510(k) summary that includes performance data)
- A design validation report
Without such a document, I am unable to describe the acceptance criteria and the study that proves the device meets them as requested in the prompt.
§ 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).