(25 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and details based on the input document. The document primarily focuses on the regulatory clearance process and states that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't necessitate new clinical study data for FDA clearance in this instance.
§ 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).