(197 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
Not Found
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets them. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on 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).