View all text of Subpart B [§ 868.1030 - § 868.1975]
§ 868.1150 - Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
(a) Identification. An indwelling blood carbon dioxide partial pressure P
(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.”