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Use during mask ventilation to assist in the determination of a patent airway.

Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.

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This document is a 510(k) premarket notification letter from the FDA for a medical device called "Pedi CO2 Easy". It primarily focuses on the regulatory approval process and includes the indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based solely on this document. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, which is the basis for its approval, but it does not detail the technical studies that would typically include acceptance criteria and performance data.

To answer your request, I would need access to the actual 510(k) submission document (not just the FDA's decision letter), which would contain the performance testing results and study design.

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Use during mask ventilation to assist in the determination of a patent airway. Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "CO2 Easy," a Carbon Dioxide Gas Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information about acceptance criteria, device performance results, specific study methodologies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) summary report or other supporting documentation submitted to the FDA, not in the clearance letter itself.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory approval, not a scientific study report.

Ask a specific question about this device