(146 days)
The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
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The provided text is a 510(k) clearance letter from the FDA for the PMP4 Application, a network and communication physiological system. While it indicates the device is substantially equivalent to a predicate device and states its intended use, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9 based on the provided text. This document is a regulatory approval notice, not a study report.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).