(90 days)
The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.
Oscillomate 9001 Non-invasive Blood Pressure Monitor
This document is a 510(k) clearance letter from the FDA for the Oscillomate EMS NIBP Monitor Model 9001. It does not contain information on acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on the regulatory clearance of the device due to its substantial equivalence to a legally marketed predicate device.
§ 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).