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The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.

The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance. The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.

The provided text does not contain detailed acceptance criteria for a device, nor does it describe a study explicitly proving that the device meets such criteria. The document is primarily a 510(k) summary for a Special 510(k) submission regarding a "NIV option for Servo-i" ventilator and concerns its substantial equivalence to predicate devices.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically, the document focuses on:

• Identifying the device and its manufacturer.
• Listing predicate devices.
• Briefly describing the device as a software-controlled feature for the Servo-i ventilator, designed to handle non-invasive ventilation with features like disconnect/leakage detection.
• Stating that the intended uses and indications are largely the same as the unmodified Servo-i, with a minor change in the lower range for infant use with the NIV option.
• The FDA letter confirms the substantial equivalence determination but does not delve into detailed performance acceptance criteria or study results demonstrating compliance with such criteria.

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