View all text of Subpart B [§ 868.1030 - § 868.1975]
§ 868.1200 - Indwelling blood oxygen partial pressure (PO2) analyzer.
(a) Identification. An indwelling blood oxygen 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.”