(37 days)
The Bernoulli VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator and respiratory gas monitor data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.
Not Found
This document is a 510(k) premarket notification FDA clearance letter for the Bernoulli™ Ventilator Management System. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.
The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a legally marketed device, but the letter does not include details of performance studies or acceptance criteria themselves.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as the full 510(k) submission or a detailed performance study report for the Bernoulli™ Ventilator Management System.
§ 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).