U.S. FDA Medical Device Blood Carbon Dioxide Partial Pressure Analyzer Requirements: Blood Carbon Dioxide Partial Pressure Analyzer
FDA Medical Device Definition: An indwelling blood carbon dioxide partial pressure PCO2analyzer is a device that consists of a catheter-tip PCO2transducer (e.g., PCO2electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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