(42 days)
The Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.
Not Found
The provided text is a 510(k) premarket notification approval letter for a medical device (Pro-Flow MultiPurpose Cannula), along with its indication for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed study parameters requested in the prompt.
Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is substantially equivalent to a legally marketed predicate device but does not include any performance data or a description of a study.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).