(116 days)
Kinetik BPM1 Series is for use at home and is a non-invasive blood pressurement system intended to measure the diastolic and systelle blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Not Found
This is a 510(k) clearance letter for a non-invasive blood pressure measurement system (Kinetik BPM1 Series). The document states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. The document is primarily a regulatory clearance, not a performance study report.
§ 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).