(99 days)
The INDEX™ BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate.
The INDEX™ BPM device is a tubeless blood pressure monitor.
I am sorry, but the provided documentation does not contain information about the acceptance criteria or any study details that prove the device meets these criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, which primarily focuses on the regulatory aspects of the device, its intended use, and substantial equivalence to a predicate device, rather than detailed performance study results.
§ 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).