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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.

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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.

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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.

Ask a specific question about this device