§ 868.1150. Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
108 words·~1 min read·
/us/cfr/t21/s§ 868.1150·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) 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.
(b)Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.” [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]
Connections4 cite this
Citation graph
cites case law
§ 868.1150
Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
Fed. Reg.×4
Cites 0Cited by 4 across 1 source