(49 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 blood 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.
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I'm sorry, but without the actual study or a detailed summary of its contents, I cannot provide the requested information about acceptance criteria and device performance. The provided text is a letter from the FDA regarding a 510(k) premarket notification for the Bernoulli™ Ventilator Management System, which acknowledges receipt and substantial equivalence to legally marketed predicate devices. It does not contain details about specific acceptance criteria, study methodologies, results, or the other specific points you've requested.
§ 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).