(34 days)
The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")
Rossmax Automatic Blood Pressure Monitor, model CardioCare 1000i
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill the request using only the provided text. The document confirms that the device, Rossmax Automatic Blood Pressure Monitor, Model CardioCare 1000i, is substantially equivalent to legally marketed predicate devices for measuring systolic, diastolic, and pulse rates in adults with a specific arm circumference. However, it does not detail the technical studies or their results that would underpin this equivalence.
§ 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).