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The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring. procedures.

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This appears to be a 510(k) clearance letter from the FDA for the Bernoulli™ Management System. This document does not contain the specific acceptance criteria and detailed study results that you are asking for.

FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a predicate device, meaning it's as safe and effective as a device already on the market. They typically do not include the detailed performance study results or acceptance criteria used by the manufacturer during their development and validation process. Those details would normally be found in the 510(k) submission itself, which is a confidential document submitted to the FDA by the manufacturer.

Therefore, I cannot provide the information you requested based on the provided text.

To answer your questions, I would need to analyze the actual 510(k) summary, often referred to as the "510(k) Premarket Notification." Sometimes, manufacturers publish these summaries publicly.

If you can provide the 510(k) Summary document for K061932, I could potentially extract the requested information.

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